NCT01288677

Brief Summary

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 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

January 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

January 13, 2011

Last Update Submit

March 19, 2013

Conditions

Healthy Volunteer

Keywords

Healthy volunteerTMC649128HPC1001TMC649128HCVHepatitis Chealthy volunteersPhase I trial

Outcome Measures

Primary Outcomes (4)

  • Number of volunteers with adverse events, if any

    Up to Day 4

  • Laboratory evaluations of blood and urine samples

    Up to Day 4

  • Vital signs evaluations

    Up to Day 4

  • Electrocardiogram evaluations

    Up to Day 4

Secondary Outcomes (1)

  • Plasma concentration of TMC649128 after a single oral dose of TMC649128 in healthy volunteers in fed conditions

    Measured on Day 1 to Day 4

Study Arms (1)

001

EXPERIMENTAL

TMC649128 Escalated doses

Drug: TMC649128

Interventions

TMC649128DRUG

Escalated doses

001

Eligibility Criteria

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

You may qualify if:

  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
  • Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker for at least 3 months prior to selection
  • Women must be postmenopausal for at least 2 years and/or be surgically sterile.

You may not qualify if:

  • Infection with Hepatitis A, B or C virus
  • infection with the Human Immunodeficiency Virus (HIV)
  • History of, or any current medical condition which could impact the safety of the participant in the study
  • A positive urine drug test at screening
  • History of any drug allergy or clinically relevant skin disease
  • Participation in an investigational drug trial or received an investigational vaccine within 30 days prior to intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 20, 2013

Record last verified: 2013-03