健康な成人参加者を対象とした MK-8507 とイスラトラビル (MK-8591) の研究 (MK-8507-016)
健康な成人参加者におけるMK-8507の週複数回投与とイスラトラビル（MK-8591）の単回投与の間の二元相互作用を評価する非盲検試験
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Nebraska
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Lincoln、Nebraska、アメリカ、68502
- Celerion (Site 0001)
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer with protocol specified exceptions
研究計画
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：なし
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
Oral administration Oral administration
他の名前：
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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 |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Maximum Concentration (Cmax) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
時間枠：At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
AUC0-Inf of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of Islatravir
時間枠：At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
C168 of Islatravir
時間枠：At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
t1/2 of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent clearance (CL/F) of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
時間枠：At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of MK-8507
時間枠：At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of MK-8507
時間枠：At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
C168 of MK-8507
時間枠：At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of MK-8507
時間枠：At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
t1/2 of MK-8507
時間枠：At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the t1/2 of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
CL/F of MK-8507
時間枠：At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
Vd/F of MK-8507
時間枠：At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
時間枠：Up to approximately 5 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
Up to approximately 5 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
時間枠：Up to approximately 5 months
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 5 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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