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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: VCH-222; Drug: telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958152

VX09-222-002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Cohort 1

Experimental group

Treatment:

Drug: VCH-222

Drug: VCH-222

Drug: telaprevir

Drug: VCH-222

Cohort 2

Experimental group

Treatment:

Drug: VCH-222

Drug: VCH-222

Drug: telaprevir

Drug: VCH-222

Cohort 3

Experimental group

Treatment:

Drug: VCH-222

Drug: VCH-222

Drug: telaprevir

Drug: VCH-222