T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
2021年9月10日 更新者：Corcept Therapeutics
A Randomized, Partial Double-Blind, Placebo- and Positive- Controlled, Multiple-Dose, 4-Way Crossover, Thorough QT/QTc (TQT) Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.
調査の概要
詳細な説明
This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control.
The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval.
Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods.
Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.
研究の種類
介入
入学 (実際)
36
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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Missouri
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Springfield、Missouri、アメリカ、65802
- Single 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～55年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Participant with a BMI ≥18.0 kg/m^2 and ≤30.0 kg/m^2 at screening
- No clinically significant abnormal findings with the physical examination, medical/surgical/medication history, vital signs, or clinical laboratory assessments and adequate cardiac conduction by electrocardiogram (ECG) without evidence of first-, second- or third-degree atrioventricular block
- Female participants of childbearing potential with a negative serum pregnancy test at screening and urine pregnancy test on Day -1 of Period 1
- All male participants agree to use condom to prevent exposure to partner; male participants with female partner of childbearing potential to use a second method of contraception
- Female participants of childbearing potential agree to use the highly effective contraception of low user dependency
- Participant is willing and able to comply with all study procedures and restrictions
- Participant understands the study procedures and agrees to participate by providing written informed consent.
Exclusion Criteria:
- Participant with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, endocrine, immunologic, dermatologic, neurological, psychiatric disease or disorder or any uncontrolled medical illness which in the opinion of the investigator would jeopardize the safety of the participant, interfere with study assessments, or impact the validity of the study results
- Participant with a history or family history of additional risk factors for Torsade de Pointe (TdP)
- Participant with a marked prolongation of ECG intervals, including QTcF >450 milliseconds (msec), PR >200 msec, or QRS >120 msec
- Participant with resting heart rate of <45beats per minute (bpm) or >100 bpm
- Participant with clinically significant abnormal ECG results
- Participant who uses medications that could prolong the QT/QTc interval
- Participant taking medications/dietary supplements that are highly dependent on cytochrome (CYP)3A for clearance and cannot undergo dose modification upon co-administration with strong CYP3A inhibitors
- Participant using any strong CYP3A inhibitor/inducer or any other medications prohibited per protocol
- Participant who is receiving testosterone within 40 days prior to study start
- Participant with a positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
- Participant with a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19)
- Participant who has travelled abroad within 3 months prior to the screening visit or plans to travel abroad during the study
- Participant who has had a major surgery within the last 28 days prior to Screening
- Participant who received any investigational product within 30 days prior to Screening
- Participant who has a known or suspected allergy, or sensitivity to study products, or any of its ingredient(s), or to moxifloxacin
- Intolerance to repeated venipuncture or inability to swallow capsules
- Donation of blood within 56 days or plasma within 14 days prior to Screening or plans to donate during the entire study period
- Positive alcohol test and/or positive drugs of abuse screen or reports of a history of substance or alcohol abuse within 1 year prior to Screening
- Female participant who is pregnant, breastfeeding, or is planning to become pregnant during the entire study period
- Male participant with pregnant partner.
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：クロスオーバー割り当て
- 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：Treatment Sequence 1
Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 2
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 3
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 4
Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 5
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 6
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 7
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 8
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 9
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 10
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 11
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
実験的：Treatment Sequence 12
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
他の名前：
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
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 |
時間枠 |
|---|---|
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Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline in Cardiac QTcF
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Heart Rate (HR)
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in HR
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Change from Baseline in Cardiac PR Interval
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
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Placebo-corrected Change from Baseline in Cardiac PR Interval
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Change from Baseline in Cardiac QRS Intervals
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Placebo-corrected Change from Baseline in Cardiac QRS Intervals
時間枠：Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Number of Participants with a Categorical Outlier in QTcF
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
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Number of Participants with a Categorical Outlier in HR
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
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Number of Participants with a Categorical Outlier in PR Interval
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Categorical Outlier in QRS Intervals
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Treatment-emergent Change of T-wave Morphology
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Treatment-emergent Presence of U-waves
時間枠：Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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|
Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
時間枠：Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
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Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
時間枠：Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
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Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
時間枠：Before dosing on Day 5 of each treatment period
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Before dosing on Day 5 of each treatment period
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Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
時間枠：Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
時間枠：Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Number of Participants with One or More Adverse Events
時間枠：Up to Day 6 in each treatment period (up to 51 days)
|
Up to Day 6 in each treatment period (up to 51 days)
|
|
Number of Participants Discontinued From Study Treatment due to an Adverse Event
時間枠：Up to Day 6 of each treatment period (up to 51 days)
|
Up to Day 6 of each treatment period (up to 51 days)
|
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
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)
2021年1月22日
一次修了 (実際)
2021年5月17日
研究の完了 (実際)
2021年7月13日
試験登録日
最初に提出
2021年1月29日
QC基準を満たした最初の提出物
2021年3月11日
最初の投稿 (実際)
2021年3月12日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月14日
QC基準を満たした最後の更新が送信されました
2021年9月10日
最終確認日
2021年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CORT125134-130
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?
いいえ
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
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Relacorilantの臨床試験
-
University of ChicagoNational Cancer Institute (NCI); Corcept Therapeutics募集
-
Corcept Therapeutics積極的、募集していないクッシング症候群アメリカ, オーストリア, ブルガリア, カナダ, ドイツ, イスラエル, イタリア, オランダ, ポーランド, ルーマニア, スペイン
-
Corcept Therapeutics積極的、募集していない再発卵管がん | 再発原発性腹膜癌 | 再発卵巣がんアメリカ, ベルギー, カナダ, イタリア, スペイン
-
Corcept Therapeutics完了
-
University of Chicago募集
-
Corcept Therapeutics完了
-
Corcept Therapeutics終了しました
-
Corcept TherapeuticsGynecologic Oncology Group積極的、募集していない卵管腫瘍 | 腹膜腫瘍 | 卵巣腫瘍アメリカ, アルゼンチン, オーストラリア, ベルギー, ブラジル, カナダ, フランス, ハンガリー, イスラエル, イタリア, 大韓民国, ポーランド, スペイン, イギリス