A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine 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
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat in plasma
研究概览
简要总结
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called carbamazepine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Gallstones, hepatitis disease, or hepatic porphyrias
- •Psychosis
- •Clinically significant hypotension, cardiac arrhythmia, cardiac conduction abnormalities, or recurrent unexplained syncopal events
- •Second- or third-degree atrioventricular heart block
- •Clinically significant sick sinus syndrome
- •Recurrent seizures, increased risk for seizures, or myasthenia gravis
- •Clinically significant hematologic disorders/blood dyscrasias, including adverse hematologic reactions to any drugs or experimental therapies
- •Any systemic fungal infection
- •Chronic infection
- •Hypothyroidism
- •Unexplained electrolyte abnormalities, current hyponatremia, diuretic use, or syndrome of inappropriate antidiuretic hormone secretion (siADH)
- •Severe dermatologic reaction
- •Stomach ulcer
- •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 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
Opevesostat Period 1
On Day 1 a single dose of opevesostat will be administered under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Opevesostat (Drug)
Opevesostat Period 1
On Day 1 a single dose of opevesostat will be administered under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Prednisone (Drug)
Opevesostat Period 1
On Day 1 a single dose of opevesostat will be administered under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Fludrocortisone acetate (Drug)
Opevesostat Period 2
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.
干预措施: Opevesostat (Drug)
Opevesostat Period 2
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.
干预措施: Prednisone (Drug)
Opevesostat Period 2
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.
干预措施: Fludrocortisone acetate (Drug)
Opevesostat Period 2
There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first carbamazepine dosing in Period 2. In Period 2, carbamazepine will be administered twice daily (BID) for 17 consecutive days with a single dose of opevesostat coadministered on the morning of Day 14 under fasting conditions. HRT (prednisone and fludrocortisone) will be administered under fed conditions on Day 14, approximately 4.5 hours after opevesostat and/or carbamazepine dosing.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
AUC0-inf of opevesostat in plasma will be determined.
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
AUC0-last of opevesostat in plasma will be determined.
Area under the concentration versus time curve from 0 to hour 24 (AUC0-24) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 24 hours post-dose
AUC0-24 of opevesostat in plasma will be determined.
Maximum concentration (Cmax) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
Cmax of opevesostat in plasma will be determined.
Time to Maximum concentration (Tmax) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
Tmax of opevesostat in plasma will be determined.
Apparent terminal half-life (t1/2) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
t1/2 of opevesostat in plasma will be determined.
Apparent Clearance (CL/F) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
CL/F of opevesostat in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of opevesostat in plasma
时间窗: Predose, and at designated timepoints up to 96 hours post-dose
Vz/F of opevesostat in plasma will be determined.
次要结局
- Number of participants who experience one or more adverse events (AEs)(Up to approximately 49 days)
- Number of participants who discontinue study intervention due to an AE(Up to approximately 49 days)