Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
- Registration Number
- NCT00958152
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
- Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg
Exclusion Criteria
- Women of child bearing potential
- Subjects positive for Hepatitis B, Hepatitis C, or HIV
- Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 VCH-222 - Cohort 3 telaprevir - Cohort 2 VCH-222 - Cohort 2 telaprevir - Cohort 1 VCH-222 - Cohort 1 telaprevir -
- Primary Outcome Measures
Name Time Method Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events Day 47 safety assessment
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state Day 37 pharmacokinetic assessment Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state Day 37 pharmacokinetic assessment