健康な参加者におけるGSK3494245の安全性、忍容性および薬物動態（PK）調査
2026年4月8日 更新者：GlaxoSmithKline
健康な参加者におけるGSK3494245の単回投与（摂食状態と絶食状態の両方）の安全性、忍容性、および薬物動態を評価するための無作為化、二重盲検、プラセボ対照、初めてのヒト研究
これは、GSK3494245 の単回投与の安全性、忍容性、および PK を評価するための第 1 相、二重盲検、無作為化、プラセボ対照、初めてのヒト (FTIH) 試験です。
この研究は、3 つのコホートで構成され、順次実施されます。
コホート 1 および 2 は、各参加者が最大 3 回の GSK3494245 の漸増経口用量と絶食条件下での 1 回のプラセボ用量を受け取る単回漸増用量 (SAD) のクロスオーバー デザインで構成されます。
各用量レベルで、GSK3494245 とプラセボを 3:1 の比率で各期間内に無作為化スケジュールに従って盲検法で投与します。
コホート 3 は、1:1 の比率で絶食後に摂食した条件下での 1 つの投薬計画と、摂食後に絶食した条件下での 1 つの投薬計画を含む 2 方向のクロスオーバーで構成されます。
給餌条件は、食品投与後のGSK3494245の単回投与の安全性、忍容性、およびPKの影響を調査します。
調査の概要
詳細な説明
The study originally planned to include 2 parts - a single ascending doses (SAD) part and a multiple ascending doses (MAD) part, incorporating a food effect component to investigate the influence of food on the PK of GSK3494245.
However, only the SAD part was conducted due to a decision to terminate the study early.
研究の種類
介入
入学 (実際)
59
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cambridge、イギリス、CB2 2GG
- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～50年 (大人)
健康ボランティアの受け入れ
はい
説明
包含基準
- -参加者は、インフォームドコンセントに署名した時点で、18歳から50歳以下でなければなりません。
- -参加者は、病歴、身体検査、臨床検査、心臓モニタリングなどの医学的評価に基づいて、治験責任医師または医学的に資格のある被指名者によって決定されたように健康でなければなりません。 研究対象集団の正常な参照範囲外で、包含または除外基準に具体的に記載されていない臨床的異常または検査パラメータを持つ参加者は、治験責任医師がメディカルモニターと相談している場合にのみ含めることができます（必要に応じて）調査結果が追加の危険因子を導入する可能性は低く、研究手順を妨げないことに同意し、文書化します。
- 体重 >= 50 キログラム (kg) で、体格指数 (BMI) が 18.5 ～ 28 キログラム/平方メートル (kg/m^2) の範囲内 (包括的)。
- 男性参加者のみ。 生殖能力のある女性パートナーを持つ男性参加者は、介入期間中および研究治療の最後の投与後少なくとも90日間は避妊を使用することに同意し、この期間中は精子の提供を控える必要があります。
- -インフォームドコンセントフォーム（ICF）およびプロトコルに記載されている要件と制限への準拠を含む、署名されたインフォームドコンセントを提供できます。
除外基準
- -心血管、呼吸器、肝臓、腎臓、胃腸、内分泌、血液、または神経学的障害の病歴または存在 薬物の吸収、代謝、または排泄を著しく変化させることができる;研究治療を受ける際のリスクを構成する;またはデータの解釈を妨害します。
- 研究者によって決定された異常な血圧。
- リーシュマニア症の既往歴。
- アラニンアミノトランスフェラーゼ（ALT）が正常上限（ULN）の1.5倍を超える。
- -ULNの1.5倍を超える総ビリルビン（総ビリルビンが分画され、直接ビリルビンが35パーセント[％]未満の場合、ULNの1.5倍を超える分離型ビリルビンは許容されます）。
- -肝疾患の現在または慢性の病歴、または既知の肝または胆道の異常（ギルバート症候群または無症候性胆石を除く）。
- -臨床的に重大な胃炎または胃十二指腸潰瘍の現在または履歴、または非ステロイド性抗炎症薬（NSAID）の定期的な使用。
- 週に 14 単位を超えるアルコールの消費 (男性ボランティア)。
- -研究者の臨床的判断に基づくもっともらしい臨床的説明のない、味覚または嗅覚の変化の現在または履歴。
- -3回のECGの平均に基づく450ミリ秒（msec）を超えるQTc。
- 早期心室収縮 (PVC) トリプレットおよび 24 時間で 500 以上の単一 PVC を含む波形異常、または調査者の裁量によるその他の異常。
- -心不整脈または心疾患の病歴、またはQT延長症候群の家族歴または個人歴。
- -ハーブ薬、NSAID、プロトンポンプ阻害剤（PPI）または抗ヒスタミン2受容体（H2）拮抗薬を含む市販薬または処方薬の過去または意図した使用 7日以内（または薬物が潜在的な酵素である場合は14日）インデューサー) または 5 半減期 (いずれか長い方) 投与前。 他の併用薬は、調査員が医療モニターと相談してケースバイケースで検討する場合があります。 パラセタモールは許可されています (上限は 2 グラム/日まで)。
- -56日間で500ミリリットル（mL）を超える血液または血液製剤の損失をもたらす研究への参加。
- 最初の投与日から 12 か月以内に 4 つ以上の新しい化学物質にさらされた。
- -過去30日以内の現在の登録または過去の参加 調査研究介入またはその他の種類の医学研究を含む他の臨床研究への同意に署名する前。
- -この臨床研究への現在の登録または過去の参加。
- -年齢に応じた糸球体濾過率（GFR）<90（ミリリットル/分/1.73メートル平方[mL/min/1.73m^2]）の慢性腎臓病疫学共同（CKD-EPI）として定義された腎機能を有する参加者。
- -尿アルブミンのスクリーニング：クレアチニン比> 30ミリグラム/グラム（mg / g）（> 3ミリグラム/ミリモル[mg / mmol]）
- -スクリーニング時のB型肝炎表面抗原（HBsAg）検査結果の存在。
- -スクリーニング時のC型肝炎抗体検査結果が陽性。
- -スクリーニング時のC型肝炎リボ核酸（RNA）検査結果が陽性。
- 陽性のヒト免疫不全ウイルス（HIV）抗体検査。
- -臨床的に重大な血尿および/またはタンパク尿の存在。
- -スクリーニング前3か月以内の喫煙または履歴、またはタバコまたはニコチン含有製品の定期的な使用を示す一酸化炭素レベル。
- 肯定的な研究前の薬物/アルコールスクリーニング。
- 既知の乱用薬物の定期的な使用。
- 食物影響コホート 3 のみ: 参加者は、食事制限 (例: 乳糖不耐症) を持っていないか、ゼラチンまたは適合した標準的な食事 (35-40% の脂肪分を含む) を食べることができない必要があります。
- 食物影響コホート 3 のみ: 胆嚢の手術または胆嚢の除去の履歴、または急性疾患状態の履歴 (例: -研究治療を受ける前の14日以内の胆石症）。
- -参加者は、スクリーニング前の6か月間にリーシュマニア/寄生虫感染症の有病率が高い地域（調査官によって決定された）に旅行してはならず、または研究治療の最終投与後3か月以内にそうするつもりです。
- -治験責任医師またはGSKメディカルモニターの意見では、研究への参加を禁忌とする研究治療またはその構成要素、または薬物またはその他のアレルギーに対する感受性。
- 検査室でコロナウイルス病 2019 (COVID-19) 感染の陽性確認、または COVID-19 の疑いの高い臨床指標。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Cohort 1 Treatment Sequence (Seq) 1: GSK3494245 20 milligram (mg) fasted/Placebo (PBO)
Participants received 20 mg of GSK3494245 during dosing period 1 and Placebo matching the active dose amount during dosing period 2 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
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実験的：Cohort 1 Treatment Seq 2: PBO/GSK3494245 40mg fasted
Participants received Placebo during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
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実験的：Cohort 1 Treatment Seq 3: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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実験的：Cohort 1 Treatment Seq 4: GSK3494245 20mg fasted/GSK3494245 40mg fasted
Participants received 20 mg of GSK3494245 during dosing period 1 and 40 mg of GSK3494245 during dosing period 2 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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実験的：Cohort 2 Treatment Seq 1:GSK3494245 40mg fasted/GSK3494245 80mg fasted/GSK3494245 120mg fasted/PBO
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and matching Placebo during dosing period 4 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
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実験的：Cohort 2 Treatment Seq 2:GSK3494245 40mg fasted/GSK3494245 80mg fasted/PBO/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, 80 mg of GSK3494245 during dosing period 2, matching placebo during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 2 Treatment Seq 3:GSK3494245 40mg fasted/PBO/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received 40 mg of GSK3494245 during dosing period 1, matching placebo during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 2 Treatment Seq 4: PBO/GSK3494245 80mg fasted/GSK3494245 120mg fasted/GSK3494245 160mg fasted
Participants received placebo during dosing period 1, 80 mg of GSK3494245 during dosing period 2, 120 mg of GSK3494245 during dosing period 3 and 160 mg of GSK3494245 during dosing period 4 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 2A Treatment Seq 1: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
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Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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実験的：Cohort 2A Treatment Seq 2: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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実験的：Cohort 2A Treatment Seq 3: GSK3494245 150mg fasted
Participants received 150 mg of GSK3494245 during dosing period 1 under fasted conditions, at Day 1.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
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実験的：Cohort 2A Treatment Seq 4: PBO fasted
Participants received Placebo during dosing period 1 under fasted conditions, at Day 1.
|
Matching placebo capsules were provided
|
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実験的：Cohort 3 Treatment Seq 1: PBO fed/PBO fasted/GSK3494245 80mg fasted/GSK3494245 80mg fed
Participants received Placebo in fed conditions during dosing period 1, Placebo in fasted conditions during dosing period 2, 80 mg of GSK3494245 in fasted conditions during dosing period 3 and 80 mg of GSK3494245 in fed conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3 Treatment Seq 2: PBO fasted/GSK3494245 80mg fed/PBO fed/GSK3494245 80mg fasted
Participants received Placebo in fasted conditions during dosing period 1, 80 mg of GSK3494245 in fed conditions during dosing period 2, placebo in fed conditions during dosing period 3 and 80 mg of GSK3494245 in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3 Treatment Seq 3: GSK3494245 80mg fed/GSK3494245 80mg fasted/PBO fasted/PBO fed
Participants received 80 mg of GSK3494245 in fed conditions during dosing period 1, 80 mg of GSK3494245 in fasted conditions during dosing period 2, Placebo in fasted conditions during dosing period 3 and placebo in fed conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3 Treatment Seq 4: GSK3494245 80mg fasted/PBO fed/GSK3494245 80mg fed/PBO fasted
Participants received 80 mg of GSK3494245 in fasted conditions during dosing period 1, Placebo in fed conditions during dosing period 2, 80 mg of GSK3494245 in fed conditions during dosing period 3 and placebo in fasted conditions during dosing period 4.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3A Treatment Seq 1: PBO fed/GSK3494245 240mg fed
Participants received placebo in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3A Treatment Seq 2: GSK3494245 160mg fed/PBO fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and Placebo in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
Matching placebo capsules were provided
|
|
実験的：Cohort 3A Treatment Seq 3: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
|
|
実験的：Cohort 3A Treatment Seq 4: GSK3494245 160mg fed/GSK3494245 240mg fed
Participants received 160 mg of GSK3494245 in fed conditions during dosing period 1 and 240 mg of GSK3494245 in fed conditions during dosing period 2.
|
Capsule of 10-250 mg dose strength were provided in labelled High Density Polyethylene (HDPE) bottles.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Adverse Events (AEs)
時間枠：From Day 1 (first dose) up to 14 days post last dose in each treatment period
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
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From Day 1 (first dose) up to 14 days post last dose in each treatment period
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Number of Participants With Serious Adverse Events (SAEs)
時間枠：From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
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A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
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From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
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Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
時間枠：From Day 1 (first dose) up to 2 days post last dose in each treatment period
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A TEAE and treatment emergent SAE is considered any untoward medical occurrence in a clinical study participant, considered by the investigator to have a causal relationship with study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
From Day 1 (first dose) up to 2 days post last dose in each treatment period
|
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Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: basophils, neutrophils, eosinophils, lymphocytes, monocytes and platelets.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
Standard deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
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Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular volume.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: mean corpuscular hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: erythrocytes and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Hemoglobin
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hemoglobin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Hematology Parameters: Hematocrit and Reticulocytes
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the hematology parameters: hematocrit and reticulocytes.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT)
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: ALT, ALP, AST, CPK, and GGT.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Albumin, Protein
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: albumin and protein.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Calcium Corrected for Albumin, Glucose, Lactic Acid, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, and Urea
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for clinical chemistry parameters: bicarbonate, calcium corrected for albumin, glucose, lactic acid, magnesium, phosphate, potassium, sodium, triglycerides, urea.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
Generally, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments on Day 1 lacked timing, the first recorded was used.
If one Day 1 assessment lacked timing, the last available from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, Baseline was set to missing.
Change from baseline is defined as post-dose value minus baseline value.
SD=0.0000 indicates SD below the detectable assay limit, approximated to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: bilirubin, creatinine, direct bilirubin.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: C-reactive Protein (CRP)
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: CRP.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Clinical Chemistry Parameters: pH
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Blood samples were collected for the assessment of the clinical chemistry parameters: pH.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Number of Participants With Worst-case Urinalysis Results
時間枠：From Day 1 up to 14 Days post last dose
|
Urine samples were collected for the assessment of urinalysis parameters, which include pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
|
From Day 1 up to 14 Days post last dose
|
|
Summary of Change From Baseline in Physical Examinations: Body Mass Index (BMI)
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Vital Signs: Respiratory Rate
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Diastolic Blood Pressure, Supine Systolic Blood Pressure
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Supine Pulse Rate
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Vital Signs: Tympanic Membrane Temperature
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in Physical Examinations: Weight
時間枠：At Day 2 and Day 4 in each treatment period compared to Baseline
|
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
|
At Day 2 and Day 4 in each treatment period compared to Baseline
|
|
Summary of Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Summary of Change From Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT (QTc) Interval, QT Interval Corrected Using Bazett's Formula, QT Interval Corrected, Using Fridericia's Formula
時間枠：At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured the PR interval, QRS interval, QT interval, and QTc interval.
Baseline was defined as the last non-missing pre-dose assessment for each cohort.
In general, assessments on Study Day 1 taken before the first dose were used as Baseline.
If multiple assessments were captured on Day 1 but the time of the first assessment was missing, the first recorded assessment was used.
If only one Day 1 assessment lacked timing, the last available assessment from Day -1 or earlier was used.
If no Day 1 assessments were available, the most recent data from Day -1 or screening was used.
If all pre-dose data were missing, no derivation was performed, and Baseline was set to missing.
Change from baseline value is defined as post-dose value minus baseline value.
|
At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
|
|
Number of Participants With Abnormal Cardiac Telemetry Findings
時間枠：Up to 24 hours post first dose on Day 1
|
Telemetry is defined as the continuous monitoring of a participant's heart rate and rhythm from a remote location.
|
Up to 24 hours post first dose on Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve (AUC[0-t]) of GSK3494245 Following Single Dose Administration, Under Fasting Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-t) of GSK3494245 Following Single Dose Administration Under Fed Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-t) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to the last measurable concentration.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC-time Curve From Time Zero to Extrapolated to Infinity (AUC[0-inf]) of GSK3494245 Following Single Dose Administration Under Fasting Condition
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
AUC (0-inf) of GSK3494245 Following Single Dose Administration Under Fed Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
AUC(0-inf) was calculated by using a standard non-compartmental analysis and was defined as area under the curve from time 0 to infinity
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Maximum Observed Plasma Drug Concentration (Cmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Cmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Cmax is defined as the maximum concentration of the drug in plasma.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Tmax of GSK3494245 Following Single Dose Administration Under Fed Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Apparent Terminal Half-life (t1/2) of GSK3494245 Following Single Dose Administration Under Fasting Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
t1/2 of GSK3494245 Following Single Dose Administration Under Fed Conditions
時間枠：At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
t1/2 is defined as the time required by the plasma concentration to decline by 50%.
|
At Day 1 (post-dose) in each treatment period (1, 2, 3, and 4)
|
|
Dose-proportionality Assessment Using AUC(0-inf) Following a Single Dose of GSK3494245
時間枠：At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
|
Dose-proportionality Assessment Using Cmax Following Single Dose of GSK3494245
時間枠：At Day 1 (post-dose)
|
A power model was used to assess the dose proportionality.
A slope of 1 indicates that PK increased linearly with the dose.
A slope greater than 1 indicates that PK increased more than proportionally with increase in the dose.
|
At Day 1 (post-dose)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：GSK Clinical Trials、GlaxoSmithKline
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年9月29日
一次修了 (実際)
2024年1月14日
研究の完了 (実際)
2024年1月14日
試験登録日
最初に提出
2020年8月5日
QC基準を満たした最初の提出物
2020年8月5日
最初の投稿 (実際)
2020年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月8日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 208441
- 2019-004492-39 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
この研究の IPD は、Clinical Study Data Request サイトから入手できます。
IPD 共有時間枠
IPD は、試験の主要評価項目、主要な副次的評価項目、および安全性データの結果が発表されてから 6 か月以内に利用可能になります。
IPD 共有アクセス基準
アクセスは、研究提案が提出され、独立審査委員会から承認を得て、データ共有契約が締結された後に提供されます。
アクセスは最初の 12 か月間提供されますが、正当な理由がある場合は、さらに 12 か月まで延長することができます。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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