A Phase 1, Open-label Study in Healthy Participants to Investigate the Effect of Multiple-dose JNJ-56136379 on the Single-dose Pharmacokinetics of Bictegravir, Emtricitabine, and Tenofovir Alafenamide
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)
研究概览
简要总结
The purpose of this study is to evaluate the effect of multiple-dose JNJ-56136379 on the single-dose pharmacokinetics (PK) of the combination of bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) in healthy adult participants.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the blood biochemistry, blood coagulation, and hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day -1
- •Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- •Must have a normal 12-lead electrocardiogram (ECG) at screening, including: a) predominant sinus rhythm, b) heart rate between 45 and 100 beats per minute (bpm), extremes included, c) QT interval corrected for heart rate (QTc) interval less than or equal to (<=) 450 milliseconds (ms) in male participants/ <= 470 ms in female participants (QT interval corrected according to Fridericia [QTcF]), c) QRS interval of less than (<)120 ms, and d) PR interval <=220 ms
排除标准
- •Having donated or lost 1 or more than 1 unit of blood (500 milliliter [mL]) or had any clinically significant abnormal bleeding in the prior 60 days before the planned first administration of a study drug
- •Any history of clinically significant skin disease (as judged by the investigator) such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- •A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
- •Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
- •Clinically significant history of liver disease or renal dysfunction (estimated creatinine clearance <60 milliliter per minute [mL/min]) at screening
研究组 & 干预措施
Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379
Participants will receive a single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 1. Multiple oral doses of JNJ-56136379 once daily on Day 6 to Day 24. A single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 20.
干预措施: JNJ-56136379 (Drug)
Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379
Participants will receive a single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 1. Multiple oral doses of JNJ-56136379 once daily on Day 6 to Day 24. A single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 20.
干预措施: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) (Drug)
结局指标
主要结局
Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)
时间窗: Up to Day 25
Plasma samples will be analyzed to determine concentrations of BIC and FTC.
Plasma Concentration of Tenofovir Alafenamide (TAF)
时间窗: Up to Day 20
Plasma samples will be analyzed to determine concentrations of TAF.
Plasma Concentration of JNJ-56136379
时间窗: Up to Day 20
Plasma samples will be analyzed to determine concentrations of JNJ-56136379.
Urine Concentration of BIC, FTC and TAF
时间窗: Up to Day 22
Urine samples will be analyzed to determine concentrations of BIC, FTC and TAF.
次要结局
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of Multiple-dose JNJ-56136379 Without and With a Single dose of Combination of BIC, FTC, and TAF(Up to Day 55)
- Number of Participants with AEs as a Measure of Safety and Tolerability of JNJ-56136379(Up to Day 55)