NCT01308606

Brief Summary

The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

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
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

First QC Date

March 3, 2011

Last Update Submit

October 10, 2012

Conditions

Hepatitis C

Keywords

TMC435-TiDP16-C116TMC435-C116TMC435HCVHepatitis CHep Chealthy volunteers

Outcome Measures

Primary Outcomes (2)

  • Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule

    Over 72 hours for every treatment session

  • Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state

    Over 72 hours for every treatment session

Secondary Outcomes (5)

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

    During maximum 7 weeks

  • Percentage of abnormal values for laboratory parameters

    Up to maximum 7 weeks

  • Observed values and changes from baseline of cardiovascular variables

    Up to maximum 7 weeks

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

    Up to maximum 7 weeks

  • Physical examination findings and changes from baseline.

    Up to maximum 7 weeks

Study Arms (5)

001

EXPERIMENTAL

TMC435 gelatin capsule Single intake of one 150-mg capsule without food

Drug: TMC435 gelatin capsule

002

EXPERIMENTAL

TMC435 HPMC capsule Single intake of one 150-mg capsule without food

Drug: TMC435 HPMC capsule

003

EXPERIMENTAL

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food

Drug: TMC435 HPMC or gelatin capsule

004

EXPERIMENTAL

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast

Drug: TMC435 HPMC or gelatin capsule

005

EXPERIMENTAL

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast

Drug: TMC435 HPMC or gelatin capsule

Interventions

TMC435 HPMC capsuleDRUG

Single intake of one 150-mg capsule without food

002
TMC435 HPMC or gelatin capsuleDRUG

Single intake of one 150-mg capsule after high-fat breakfast

005
TMC435 gelatin capsuleDRUG

Single intake of one 150-mg capsule without food

001

Eligibility Criteria

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

You may qualify if:

  • Non-smokers for at least 3 months prior to screening
  • Have a body mass index of 18.0 to 30.0 kg per square meter
  • Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

You may not qualify if:

  • Use of disallowed therapies, including over-the-counter products and dietary supplements
  • Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
  • Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

Gelatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ScleroproteinsProteinsAmino Acids, Peptides, and Proteins

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

March 3, 2011

First Posted

March 4, 2011

Study Start

March 1, 2011

Study Completion

June 1, 2011

Last Updated

October 11, 2012

Record last verified: 2012-10