NCT01038167

Brief Summary

The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 8, 2010

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

December 18, 2009

Last Update Submit

April 6, 2010

Conditions

Hepatitis C

Keywords

VX-950

Outcome Measures

Primary Outcomes (3)

  • Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

    33 days

  • Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)

    33 days for Part A; 44 days for Part B

  • Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

    44 days

Secondary Outcomes (1)

  • Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations

    33 days for Part A; 44 days for Part B

Study Arms (2)

Part A

EXPERIMENTAL

Part A will be administered in two periods, separated by a washout. In Period 1, subjects will receive cyclosporine alone. In Period 2, subjects will receive cyclosporine in combination with telaprevir.

Drug: telaprevirDrug: cyclosporine

Part B

EXPERIMENTAL

Part B will be administered in two periods, separated by a washout. In Period 1, subjects will receive tacrolimus alone. In Period 2, subjects will receive tacrolimus in combination with telaprevir.

Drug: telaprevirDrug: tacrolimus

Interventions

telaprevirDRUG

Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2

Part A
cyclosporineDRUG

Solution, Oral, 100mg, Day 1 of Period 1

Part A
tacrolimusDRUG

Capsule, Oral, 2mg, Day 1 of Period 1

Part B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)
  • Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.

You may not qualify if:

  • History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
  • Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.
  • Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevirCyclosporineTacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 8, 2010

Record last verified: 2010-04

Locations

US(1)