NCT01336829

Brief Summary

The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

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

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

April 7, 2011

Last Update Submit

August 28, 2012

Conditions

Hepatitis CHIV

Keywords

Hepatitis CHIVTMC125IFD1001TMC125IntelenceetravirineETRTMC278telaprevirTVRVX-950healthy volunteerscrossover

Outcome Measures

Primary Outcomes (4)

  • Bloodlevels of telaprevir following co-administration with ETR

    Over 8 hours on day 18 of treatment B.

  • Bloodlevels of telaprevir following co-administration with TMC278

    Over 8 hours on day 18 of treatment B.

  • Bloodlevels of ETR following co-administration with telaprevir

    Over 12 hours on day 18 of treatment B.

  • Bloodlevels of TMC278 following co-administration with telaprevir

    Over 24 hours on day 18 of treatment D

Secondary Outcomes (6)

  • Number of participants with adverse events and the severity of adverse events

    Over approximately 11 weeks

  • Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19)

    1 bloodsample on day 1 of treatment A.

  • Observed values and changes from baseline for abnormal values of laboratory results.

    Over approximately 11 weeks

  • Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart)

    Over approximately 11 weeks

  • Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits

    Over approximately 11 weeks

  • +1 more secondary outcomes

Study Arms (4)

001

EXPERIMENTAL

ETR/telaprevir Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.

Drug: ETR/telaprevir

002

EXPERIMENTAL

telaprevir/ETR Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.

Drug: telaprevir/ETR

003

EXPERIMENTAL

TMC278/telaprevir Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18.

Drug: TMC278/telaprevir

004

EXPERIMENTAL

telaprevir/TMC278 Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18.

Drug: telaprevir/TMC278

Interventions

ETR/telaprevirDRUG

Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.

001
TMC278/telaprevirDRUG

Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.

003
telaprevir/ETRDRUG

Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.

002
telaprevir/TMC278DRUG

Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.

004

Eligibility Criteria

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

You may qualify if:

  • Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
  • A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2
  • Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening
  • Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.

You may not qualify if:

  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
  • A positive urine drug test at Screening
  • Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements
  • History of significant drug allergy
  • Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

Related Publications (1)

  • Kakuda TN, Leopold L, Nijs S, Vandevoorde A, Crauwels HM, Bertelsen KM, Stevens M, Witek J, van Delft Y, Tomaka F, Hoetelmans RM. Pharmacokinetic interaction between etravirine or rilpivirine and telaprevir in healthy volunteers: A randomized, two-way crossover trial. J Clin Pharmacol. 2014 May;54(5):563-73. doi: 10.1002/jcph.245.

    PMID: 25975423DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Rilpivirinetelaprevir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 18, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

BE(1)