A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
An Open-Label, Multiple-dose, Parallel Group Study to Evaluate the Pharmacokinetics of MK-6916 in Participants With Severe Renal Impairment and Moderate Renal Impairment
The purpose of this study is to learn what happens to MK-6916 in a person's body when given to participants with moderate or severe kidney impairment compared to healthy participants.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
参加基準
適格基準
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 main inclusion criteria include but are not limited to the following:
Moderate and Severe Renal Impairment
- Except for severe or moderate renal impairment, is sufficiently healthy for study participation
- Has stable renal function Healthy
- Matches mean age to participants with moderate and severe renal impairment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost 1 unit of blood within 4 weeks prior to pretrial Participants with Renal Impairment
- Has a history of renal artery stenosis, failed renal transplant or has had a nephrectomy, or end stage renal disease requiring dialysis
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Panel A: Severe Renal Impairment
Participants with severe renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
|
実験的：Panel B: Moderate Renal Impairment
Participants with moderate renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
|
実験的：Panel C: Healthy
Healthy participants will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
この研究は何を測定していますか？
主要な結果の測定
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 12 Hours (AUC0-12) of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUC0-12 of MK-6916 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Plasma Concentration at 12 Hours (C12) of MK-6916 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916. |
Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-6916 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Apparent Terminal Half-life (t1/2) of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Clearance at Steady State (CL,ss/F) of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the CL,ss/F of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Apparent Volume of Distribution at Steady State (Vz,ss/F) of MK-6916 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Vz,ss/F of MK-6916 |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M5 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M9 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M10 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M5 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M9 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M10 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Cmax of MK-6916 Metabolite M5 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M5 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M9 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M9 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M10 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M10 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
C12 of MK-6916 Metabolite M5 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M5 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M9 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M9 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M10 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M10 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Tmax of MK-6916 Metabolite M5 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M5 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M9 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M9 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M10 on Day 1
時間枠：Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M10 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M5 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M9 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M10 on Day 16
時間枠：Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Number of Participants Who Experience an Adverse Event (AE)
時間枠：Up to approximately 75 days
|
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 75 days
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
時間枠：Up to approximately 16 days
|
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 16 days
|
協力者と研究者
捜査官
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 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
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
その他の研究ID番号
- 6916-013
- MK-6916-013 (その他の識別子：MSD)
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?
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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
米国FDA規制機器製品の研究
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。