Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lersivirine; Drug: Rifabutin

• Registration Number: NCT00925535
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Study Start: 2010-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Disposition First Submitted: 2010-09-02
• Disposition First Submitted QC: 2010-09-02
• Disposition First Posted: 2010-09-08
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• Hypersensitivity/allergic reactions to any component of the study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Lersivirine	Lersivirine
Treatment B	Rifabutin	Rifabutin
Treatment C	Rifabutin	Lersivirine and Rifabutin
Treatment C	Lersivirine	Lersivirine and Rifabutin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments	58 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore