A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma
研究概览
简要总结
Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- •Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- •Able to swallow multiple tablets
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History or presence of any of the following:
- •Adrenal insufficiency
- •Hepatic or renal impairment
- •Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
- •Second- or third-degree Atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker)
- •Clinically significant sick sinus syndrome
- •Presence of any systemic fungal infection
- •Chronic infection
- •Hypothyroidism
- •Stomach ulcer
- •Ocular herpes simplex
- •Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
- •History of cancer (malignancy)
- •Unable to refrain from or anticipants the use of: Unable to refrain from or anticipates the use of: Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
研究组 & 干预措施
MK-5684 Period 1
On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing.
干预措施: MK-5684 (Drug)
MK-5684 Period 1
On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing.
干预措施: Prednisone (Drug)
MK-5684 Period 1
On Day 1 a single dose of MK-5684 will be administered under fasting conditions and a single dose of HRT (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after MK-5684 dosing.
干预措施: Fludrocortisone acetate (Drug)
MK-5684 Period 2
There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing.
干预措施: MK-5684 (Drug)
MK-5684 Period 2
There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing.
干预措施: Prednisone (Drug)
MK-5684 Period 2
There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing.
干预措施: Fludrocortisone acetate (Drug)
MK-5684 Period 2
There will be a washout of at least 5 days between MK-5684 dosing in Period 1 and the first diltiazem dosing in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 6 consecutive days with a single dose of MK-5684 coadministered on Day 2 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 2 through 5, approximately 4.5 hours after MK-5684 and/or diltiazem dosing.
干预措施: Diltiazem hydrocholoride (Drug)
结局指标
主要结局
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
AUC0-last of MK-5684 in plasma will be determined.
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
AUC0-inf of MK-5684 in plasma will be determined.
Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 24 hours post-dose
AUC0-24 of MK-5684 in plasma will be determined.
Maximum concentration (Cmax) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
Cmax of MK-5684 in plasma will be determined.
Time to Maximum concentration (Tmax) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
Tmax of MK-5684 in plasma will be determined.
Apparent terminal half-life (t1/2) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
t1/2 of MK-5684 in plasma will be determined.
Apparent Clearance (CL/F) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
CL/F of MK-5684 in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma
时间窗: Predose, and at designated timepoints up to 120 hours post-dose
Vz/F of MK-5684 in plasma will be determined.
次要结局
- Number of participants who experience one or more adverse events (AEs)(Up to approximately 39 days)
- Number of participants who discontinue study intervention due to an AE(Up to approximately 39 days)