NCT01001247 is a Phase 1 clinical trial of TMC278; Omeprazole in HIV Infections, sponsored by Tibotec Pharmaceuticals, Ireland.

Who is sponsoring NCT01001247?

NCT01001247 is sponsored by Tibotec Pharmaceuticals, Ireland.

What drugs are being tested in NCT01001247?

Interventions in NCT01001247: TMC278; Omeprazole.

What condition does NCT01001247 study?

NCT01001247 studies HIV Infections.

Is NCT01001247 still recruiting?

NCT01001247 is currently completed. Last updated 8 July 2010.

Last reviewed 2010-07-08 · How we verify

NCT01001247

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

A Phase I, Open Label, Randomized, 4-way Crossover Trial to Evaluate the Pharmacokinetics of TMC278 25mg and 50mg in the Presence of Omeprazole 20mg q.d., in Healthy Subjects

Completed Phase 1 Last updated 8 July 2010

What this trial tests

Phase 1 trial testing TMC278; Omeprazole in HIV Infections in 18 participants. Completed in 1 April 2010.

Timeline

1 January 2010

Primary endpoint
1 April 2010

1 April 2010

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	18
Start date	1 January 2010
Primary completion	1 April 2010
Estimated completion	1 April 2010

Drugs / interventions tested

TMC278; Omeprazole — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Tibotec Pharmaceuticals, Ireland — full company profile →

Who can join

Adults 18 to 55, any sex, with HIV Infections. 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 TMC278 assessed after co-administration of 20mg q.d. omeprazole taken either in the morning (1.5 h before TMC278) or in the evening (12 h before TMC278); assess 24h intragastric pH at days of intake of TMC278
Time frame: Plasma levels: Treatment A, B, C and D: Day1 (at 11 time points), Day2, 3, 4, 6 and 8 (all at 1 time point). Intragastric pH: Treatment A, B, C and D at Day1 (=day of intake TMC278).

Sponsor's own description

The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also investigates - in case levels of TMC278 are reduced when co-administered with omeprazole - whether a double dose of TMC278 (50 mg q.d.) or a separation of intake of both drugs by 12 hours may circumvent a decrease of TMC278 levels in the blood below the clinical effective concentration. Omeprazole is prescribed to reduce the production of gastric acid. Since TMC278 requires gastric acid to be properly dissolved and taken up in the blood circulation, intake of omeprazole has an influence on the levels of TMC278 in the blood circulation. This effect has been revealed in a previously conducted clinical trial, using the combination of 150 mg TMC278 q.d. and 20 mg q.d. omeprazole. The currently proposed study will also further explore the relationship between the levels of TMC278 in the blood at several time points and the acidity of the stomach. Also the short-term safety and tolerability of co-administration of omeprazole 20 mg q.d. and TMC278 25 mg q.d. will be assessed.

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:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

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 NCT01001247 (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: 8 July 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/NCT01001247.

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