A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bictegravir
研究概览
简要总结
Researchers are looking for new treatments for people living with HIV-1(Human Immunodeficiency Virus Type 1). HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
HIV-1 treatments, called ART (antiretroviral therapy), involve taking medicines to lower the amount of HIV-1 virus in the body. Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG).
MK-4646 is a trial medicine designed to treat HIV-1. Before giving a trial medicine to people with a health condition, researchers first do trials in healthy people.
The goals of this study are to learn:
- If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time.
- About the safety of MK-4646 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is in good health before randomization
- •Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
排除标准
- •Has a history of clinically significant endocrine, gastrointestinal (GI), 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
Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide (Drug)
Treatment D: MK-4646 + dolutegravir (DTG)
Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).
干预措施: Dolutegravir (Drug)
Treatment B: dolutegravir (DTG)
Participants will receive a single oral dose of dolutegravir (DTG).
干预措施: Dolutegravir (Drug)
Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide (Drug)
Treatment D: MK-4646 + dolutegravir (DTG)
Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG).
干预措施: MK4646 (Drug)
Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)
Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
干预措施: MK4646 (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bictegravir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-Inf of bictegravir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Emtricitabine
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-Inf of emtricitabine.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tenofovir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-Inf of tenofovir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Dolutegravir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-Inf of dolutegravir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of bictegravir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of emtricitabine.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of tenofovir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir
时间窗: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of dolutegravir.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 44 days)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 31 Days)
- Maximum Plasma Concentration (Cmax) of Bictegravir(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at 24 Hours (C24) of Bictegravir(At designated time points (up to approximately 24 hours post dose))
- Time to Maximum Plasma Concentration (Tmax) of Bictegravir(At designated timepoints (up to approximately 72 hours post dose))
- Apparent Terminal Half-life (t½) of Bictegravir(At designated timepoints (up to approximately 72 hours post dose))
- Maximum Plasma Concentration (Cmax) of Emtricitabine(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at 24 Hours (C24) of Emtricitabine(At designated time points (up to approximately 24 hours post dose))
- Time to Maximum Plasma Concentration (Tmax) of Emtricitabine(At designated time points (up to approximately 72 hours post dose))
- Apparent Terminal Half-life (t½) of Emtricitabine(At designated timepoints (up to approximately 72 hours post dose))
- Maximum Plasma Concentration (Cmax) of Tenofovir(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at (C24) of Tenofovir(At designated time points (up to approximately 24 hours post dose))
- Time to Maximum Plasma Concentration (Tmax) of Tenofovir(At designated timepoints (up to approximately 72 hours post dose))
- Apparent Terminal Half-life (t½) of Tenofovir(At designated timepoints (up to approximately 72 hours post dose))
- Maximum Plasma Concentration (Cmax) of Dolutegravir(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at (C24) of Dolutegravir(At designated time points (up to approximately 24 hours post dose))
- Time to Maximum Plasma Concentration (Tmax) of Dolutegravir(At designated timepoints (up to approximately 72 hours post dose))
- Apparent Terminal Half-life (t½) of Dolutegravir(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at 24 Hours (C24) of Emtricitabine(24 hours post dose)
- Plasma Concentration at 24 Hours (C24) of Bictegravir(24 hours post dose)
- Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide(At designated time points (up to approximately 24 hours post dose))
- Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide(At designated time points (up to approximately 72 hours post dose))
- Apparent Terminal Half-life (t½) of Tenofovir Alafenamide(At designated timepoints (up to approximately 72 hours post dose))
- Plasma Concentration at (C24) of Tenofovir(24 hours post dose)
- Plasma Concentration at (C24) of Dolutegravir(24 hours post dose)