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A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers

NCT01268839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-09-04

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers

Conditions

Interventions

DRUG

TMC278

25mg tablet once daily for 28 days

DRUG

TMC278

25mg tablet once daily for 14 days

DRUG

Efavirenz

600mg tablet once daily for 14 days

Sponsors & Collaborators

  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

    collaborator INDUSTRY

  • Tibotec, Inc

    lead INDUSTRY

Principal Investigators

  • Tibotec, Inc. Clinical Trial · Tibotec, Inc

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01268839 on ClinicalTrials.gov