An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the curve from time 0-infinity (AUC0-inf) of DOR
研究概览
简要总结
The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria include, but are not limited to:
- •Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- •Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
排除标准
- •Exclusion Criteria include, but are not limited to:
- •Has a history or presence 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)
研究组 & 干预措施
MK-8591A Sequence 1A
Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 1A
Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 1A
Participants will receive Doravine/Islatravir (DOR/ISL) fixed-dose combination (FDC) tablet under fasting conditions followed by a DOR/ISL FDC tablet under fed conditions followed by a single dose Doravine tablet and a single dose Islatravir capsule under fasting conditions.
干预措施: Doravine (Drug)
MK-8591A Sequence 2A
Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 2A
Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 2A
Participants will receive DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions.
干预措施: Doravine (Drug)
MK-8591A Sequence 1B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 1B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 1B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a DOR/ISL FDC tablet under fasting conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting conditions.
干预措施: Doravine (Drug)
MK-8591A Sequence 2B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 2B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 2B
Participants will receive DOR/ISL FDC tablet under fed conditions followed by a single dose DOR tablet and a single dose ISL capsule under fasting condition followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: Doravine (Drug)
MK-8591A Sequence 1C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 1C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 1C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fasting conditions followed by followed by a DOR/ISL FDC tablet under fed conditions.
干预措施: Doravine (Drug)
MK-8591A Sequence 2C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: MK-8591A (Drug)
MK-8591A Sequence 2C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: Islatravir (Drug)
MK-8591A Sequence 2C
Participants will receive a single dose DOR tablet and a single dose ISL capsule under fasting conditions followed by DOR/ISL FDC tablet under fed conditions followed by followed by a DOR/ISL FDC tablet under fasting conditions.
干预措施: Doravine (Drug)
结局指标
主要结局
Area under the curve from time 0-infinity (AUC0-inf) of DOR
时间窗: At designated time points up to ~30 days
AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR.
Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine
时间窗: At designated time points up to ~30 days
AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR. Blood will be collected at designated time points to determine the AUC0-last of DOR.
Maximum plasma concentration (Cmax) of doravine
时间窗: At designated time points up to ~30 days
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of DOR.
Plasma concentration at 24 hours postdose (C24) of DOR
时间窗: At designated time points up to ~24 hours postdose
C24 is the concentration at 24 hours postdose of the drug observed in plasma. Blood samples collected at 24 postdose will be used to determine C24 of DOR.
AUC0-inf of ISL
时间窗: At designated time points up to ~30 days
AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL.
AUC0-last of ISL
时间窗: At designated time points up to ~30 days
AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL. Blood will be collected at designated time points to determine the AUC0-last of ISL.
Cmax of ISL
时间窗: At designated time points up to ~30 days
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of ISL.
次要结局
- Number of participants who experienced an adverse event (AE)(Up to ~44 days)
- Number of participants who discontinued study intervention due to an AE(Up to ~30 days)