Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

Vertex Pharmaceuticals Incorporated30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C

Interventions

VCH-222DRUG

Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37

VCH-222DRUG

Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37

VCH-222DRUG

Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37

telaprevir

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Christchurch, New Zealand

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

Time frame: 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

Time frame: Day 37 pharmacokinetic assessment

Data from ClinicalTrials.gov

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