A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Dabigatran Etexilate (Free and Total)
研究概览
简要总结
The purpose of this study is to evaluate effect of single and repeated doses of darunavir (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total dabigatran) when co-administered in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Must have a body mass index (BMI) (weight in kilogram [kg]/height^2 in square meters [m^2] ) between 18.0 and 30.0 kg/m^2 (inclusive) and body weight not less than 50.0 kg
- •Must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study
- •A woman must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening, on Day -1 (only if the test performed at screening was greater than [>] 4 days before dosing), and at the end of the study
- •Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
- •Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug
排除标准
- •Clinically significant abnormalities during physical examination, vital signs, or 12 lead - electrocardiogram (ECG) at screening as deemed appropriate by the investigator
- •With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- •With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
- •Has donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
- •Has received an investigational drug or used an investigational medical device within 60 days before the first intake of study drug
研究组 & 干预措施
Panel 1: Dabigatran etexilate +DRV/COBI
Participants will receive Treatment A (single dose of Dabigatran etexilate orally) on Day 1 followed by Treatment B (single dose of Darunavir/ cobicistat [DRV/COBI] as fixed dose combination tablet orally and single dose of dabigatran etexilate) on Day 4 followed by Treatment C ([DRV/COBI] as fixed dose combination tablet orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
干预措施: Dabigatran Etexilate (Drug)
Panel 1: Dabigatran etexilate +DRV/COBI
Participants will receive Treatment A (single dose of Dabigatran etexilate orally) on Day 1 followed by Treatment B (single dose of Darunavir/ cobicistat [DRV/COBI] as fixed dose combination tablet orally and single dose of dabigatran etexilate) on Day 4 followed by Treatment C ([DRV/COBI] as fixed dose combination tablet orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
干预措施: DRV/COBI (Drug)
Panel 2: Dabigatran etexilate +DRV+rtv
Participants will receive Treatment D (single dose of dabigatran etexilate orally) on Day 1 followed by Treatment E (single doses of Darunavir, and ritonavir [rtv], and single dose of dabigatran etexilate on Day 4), followed by Treatment F (DRV and rtv orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
干预措施: Dabigatran Etexilate (Drug)
Panel 2: Dabigatran etexilate +DRV+rtv
Participants will receive Treatment D (single dose of dabigatran etexilate orally) on Day 1 followed by Treatment E (single doses of Darunavir, and ritonavir [rtv], and single dose of dabigatran etexilate on Day 4), followed by Treatment F (DRV and rtv orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
干预措施: Ritonavir (Drug)
Panel 2: Dabigatran etexilate +DRV+rtv
Participants will receive Treatment D (single dose of dabigatran etexilate orally) on Day 1 followed by Treatment E (single doses of Darunavir, and ritonavir [rtv], and single dose of dabigatran etexilate on Day 4), followed by Treatment F (DRV and rtv orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
干预措施: Darunavir (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Dabigatran Etexilate (Free and Total)
时间窗: Up to Day 18
AUC(0-last) is the Area under the curve (AUC) from time 0 to the time of last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Maximum Observed Analyte Concentration (Cmax) of Dabigatran Etexilate (Free and Total)
时间窗: Up to Day 18
Cmax is the maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC0-infinity) of Dabigatran Etexilate (Free and Total)
时间窗: Up to Day 18
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.
次要结局
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(From signing of the ICF up to end of study (up to 8 weeks))