NCT00958152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 7, 2010

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

August 6, 2009

Last Update Submit

January 6, 2010

Conditions

Hepatitis C

Keywords

VX-950VX-222STAT-C

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events

    Day 47 safety assessment

Secondary Outcomes (2)

  • 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

Study Arms (3)

Cohort 1

EXPERIMENTAL
Drug: VCH-222Drug: telaprevir

Cohort 2

EXPERIMENTAL
Drug: VCH-222Drug: telaprevir

Cohort 3

EXPERIMENTAL
Drug: VCH-222Drug: telaprevir

Interventions

VCH-222DRUG

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

Cohort 1
telaprevirDRUG

Tablet, Oral, 1125 mg, q12h, Days 18-37

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

lomibuvirtelaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Medical Monitor

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 7, 2010

Record last verified: 2010-01

Locations

NZ(1)