NCT00958152
Completed
Phase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- VCH-222
- Conditions
- Hepatitis C
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 30
- Primary Endpoint
- Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort 1
Intervention: VCH-222
Cohort 1
Intervention: telaprevir
Cohort 2
Intervention: VCH-222
Cohort 2
Intervention: telaprevir
Cohort 3
Intervention: VCH-222
Cohort 3
Intervention: telaprevir
Outcomes
Primary Outcomes
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Time Frame: Day 47 safety assessment
Secondary Outcomes
- 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)
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