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

Hepatitis C Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958152
• Other study ID #: VX09-222-002
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2009
• Last updated: January 6, 2010
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
• VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
• VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
• telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events		Day 47 safety assessment	Yes
Secondary	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	No
Secondary	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	No