NCT01230385 is a Phase 1 clinical trial of Lersivirine in Healthy Volunteers, sponsored by Pfizer.

Who is sponsoring NCT01230385?

NCT01230385 is sponsored by Pfizer.

What drugs are being tested in NCT01230385?

Interventions in NCT01230385: Lersivirine, Lersivirine, Lersivirine, Lersivirine, Lersivirine.

What condition does NCT01230385 study?

NCT01230385 studies Healthy Volunteers.

Is NCT01230385 still recruiting?

NCT01230385 is currently completed. Last updated 16 May 2011.

Last reviewed 2011-05-16 · How we verify

NCT01230385

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

Randomized, Open-Label, Parallel Group Study To Investigate The Safety And Tolerability Of Multiple Dose Lersivirine (Proposed Phase 3 Formulation) For 21 Days In Healthy Subjects

Completed Phase 1 Last updated 16 May 2011

What this trial tests

Phase 1 trial testing Lersivirine in Healthy Volunteers in 75 participants. Completed in 1 May 2011.

Timeline

1 October 2010

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	1 October 2010
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	2 locations across United States, Belgium

Drugs / interventions tested

Lersivirine — full drug profile →
Lersivirine — full drug profile →
Lersivirine — full drug profile →
Lersivirine — full drug profile →
Lersivirine — 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.

Number of participants with adverse events as a measure of safety and tolerability of multiple doses of lersivirine administered to healthy subjects over 21 days.
Time frame: 21 days

Sponsor's own description

Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.

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 NCT01230385 (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: 16 May 2011

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/NCT01230385.

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