Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/Hepatitis C Virus (HCV) Seronegative Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Simeprevir AUC Pharmacokinetics
研究概览
简要总结
The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.
详细描述
To investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. The pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Men and women ages 18-60 years
- •Absence of HIV-1 and HCV antibodies at screening,
- •Ability and willingness to give written informed consent before the first trial-related activity.
排除标准
- •Pregnancy
- •Breastfeeding
- •Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements
- •Participation in any investigational drug study within 30 days prior to study entry
- •Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results
- •Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives
- •Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry
- •Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis,
- •History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
- •Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS grading table") and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range (ULN)); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above.
研究组 & 干预措施
Sequence 1a
Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.
干预措施: dolutegravir (Drug)
Sequence 1a
Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir.
干预措施: simeprevir (Drug)
Sequence 1b
Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.
干预措施: dolutegravir (Drug)
Sequence 1b
Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only.
干预措施: simeprevir (Drug)
Sequence 2a
Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.
干预措施: dolutegravir (Drug)
Sequence 2a
Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir.
干预措施: simeprevir (Drug)
Sequence 2b
Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.
干预措施: dolutegravir (Drug)
Sequence 2b
Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only.
干预措施: simeprevir (Drug)
Sequence 3a
Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.
干预措施: dolutegravir (Drug)
Sequence 3a
Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only.
干预措施: simeprevir (Drug)
Sequence 3b
Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.
干预措施: dolutegravir (Drug)
Sequence 3b
Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.
干预措施: simeprevir (Drug)
结局指标
主要结局
Simeprevir AUC Pharmacokinetics
时间窗: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Determine simeprevir area-under-the concentration time curve (AUC) when administered alone and when being co-administered with Dolutegravier.
Dolutegravir AUC Pharmacokinetics
时间窗: Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose on day 7
Determine Dolutegravir area-under-the concentration time curve (AUC) when administered alone and when co-administered with simeprevir.
次要结局
未报告次要终点