Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01230385

Enrollment

Registered

2010-10-29

Start date

2010-10-31

Completion date

2011-05-31

Last updated

2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

lersivirine, UK-453, 061, safety, tolerability, pharmacokinetics, HIV, non-nucleoside reverse transcriptase inhibitor, NNRTI

Brief summary

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.

Interventions

DRUGLersivirine

Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Design outcomes

Primary

Measure	Time frame
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.	21 days

Secondary

Measure	Time frame
Lersivirine plasma pharmacokinetic parameter: AUC24, Cmax, C24, and Tmax on Day 7	21 days

Countries

Belgium, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026