NCT00854204 is a Phase 1 clinical trial of TMC114; TMC41629 in HIV-I, sponsored by Tibotec Pharmaceuticals, Ireland.

Who is sponsoring NCT00854204?

NCT00854204 is sponsored by Tibotec Pharmaceuticals, Ireland.

What drugs are being tested in NCT00854204?

Interventions in NCT00854204: TMC114; TMC41629.

Is NCT00854204 still recruiting?

NCT00854204 is currently completed. Last updated 26 April 2010.

Last reviewed 2010-04-26 · How we verify

NCT00854204

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I, Open-label, 3-way Crossover Trial in Healthy Male Volunteers to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629

Completed Phase 1 Last updated 26 April 2010

What this trial tests

Phase 1 trial testing TMC114; TMC41629 in HIV-I in 12 participants. Completed in 1 January 2009.

Timeline

1 November 2008

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Tibotec Pharmaceuticals, Ireland
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 November 2008
Primary completion	1 January 2009
Estimated completion	1 January 2009

Drugs / interventions tested

TMC114; TMC41629 — full drug profile →

Conditions studied

HIV-I — all drugs for HIV-I →

Sponsor

Tibotec Pharmaceuticals, Ireland — full company profile →

Who can join

Adults 18 to 55, male only, with HIV-I. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plasma levels of TMC114 and TMC41629 will be determined up to 72 hours after administration.

Sponsor's own description

The purpose of this study is to compare the bioavailability (the degree to which a drug becomes available in the body after administration) of 3 different pharmaceutical preparations of a combination of two drugs, TMC114 and TMC41629. There will be 1 single oral intake (intake by mouth) of each of the 3 preparations. The study will also investigate the safety of use and the potential side effects of TMC114 and TMC41629, and determine the circulating levels of both compounds in your blood over time (pharmacokinetics), after a single intake.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00854204 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tibotec Pharmaceuticals, Ireland
Last refreshed: 26 April 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00854204.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing