NCT00925535 is a Phase 1 clinical trial of Lersivirine in Healthy Volunteers, sponsored by Pfizer.

Who is sponsoring NCT00925535?

NCT00925535 is sponsored by Pfizer.

What drugs are being tested in NCT00925535?

Interventions in NCT00925535: Lersivirine, Rifabutin, Lersivirine, Rifabutin.

What condition does NCT00925535 study?

NCT00925535 studies Healthy Volunteers.

Is NCT00925535 still recruiting?

NCT00925535 is currently completed. Last updated 17 September 2010.

Last reviewed 2010-09-17 · How we verify

NCT00925535

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

Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects

Completed Phase 1 Last updated 17 September 2010

What this trial tests

Phase 1 trial testing Lersivirine in Healthy Volunteers in 18 participants. Completed in 1 August 2010.

Timeline

1 May 2010

Primary endpoint
1 August 2010

1 August 2010

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 May 2010
Primary completion	1 August 2010
Estimated completion	1 August 2010
Sites	1 location across Singapore

Drugs / interventions tested

Lersivirine — full drug profile →
Rifabutin — full drug profile →
Lersivirine — full drug profile →
Rifabutin — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

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

Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
Time frame: 20 days
Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h
Time frame: 20 days

Sponsor's own description

Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.

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:

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Other Pfizer trials

Trials by the same sponsor.

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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 NCT00925535 (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 Pfizer
Last refreshed: 17 September 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/NCT00925535.

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