A Clinical Trial of MK-7602 in Healthy Volunteers (MK-7602-006)
A Clinical Study to Evaluate the Effect of Pyronaridine on the Pharmacokinetics of MK-7602 in Healthy Participants
MK-7602 is a new medicine that is being studied to treat malaria. Malaria is a disease caused by a parasite that spreads to people through mosquito bites. Symptoms of malaria include fever, chills, and flu-like illness. If malaria is not treated, some people can have serious problems that can be deadly.
The goal of this trial is to learn what happens to MK-7602 in a person's body over time (a pharmacokinetic or PK trial). Researchers will compare what happens to MK-7602 in people's blood when it is taken alone (Period 1) and in combination with another medicine called pyronaridine (Period 2). Researchers also want to learn about the safety of MK-7602 taken with and without pyronaridine and if people tolerate them.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
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 main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
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：基礎科学
- 割り当て：非ランダム化
- 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：Period 1: MK-7602
Participants will receive an oral dose of MK-7602 once daily on Days 1, 2, and 3 of Period 1. |
Oral administration |
|
実験的：Period 2: MK-7602 + Pyronaridine
Participants will receive oral doses of MK-7602 and pyronaridine once daily on Days 1, 2, and 3 of Period 2. |
Oral administration Oral administration |
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 Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602
時間枠：At designated timepoints (up to approximately 21 days)
|
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 21 days)
|
|
Maximum Plasma Concentration (Cmax) of MK-7602
時間枠：At designated timepoints (up to approximately 21 days)
|
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 21 days)
|
|
Number of Participants Who Experience an Adverse Event (AE)
時間枠：Up to approximately 2 months
|
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who experience an AE will be reported. |
Up to approximately 2 months
|
|
Number of Participants Who Discontinue Study Intervention Due to an AE
時間枠：Up to approximately 20 days
|
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who discontinue study intervention due to an AE will be reported. |
Up to approximately 20 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUC0-tau of MK-7602
時間枠：At designated timepoints (up to approximately 19 days)
|
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 19 days)
|
|
Cmax of MK-7602
時間枠：At designated timepoints (up to approximately 19 days)
|
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine. |
At designated timepoints (up to approximately 19 days)
|
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 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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
- 7602-006
- MK-7602-006 (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
米国で製造され、米国から輸出された製品。
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