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

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

Sponsors

Lead sponsor: Pfizer

Source 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.

Overall Status Completed
Start Date May 2010
Completion Date August 2010
Primary Completion Date August 2010
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments 58 days
Enrollment 18
Condition
Intervention

Intervention type: Drug

Intervention name: Lersivirine

Description: 1000 mg once daily for 10 days

Arm group label: Treatment A

Intervention type: Drug

Intervention name: Rifabutin

Description: 300 mg once daily for 10 days

Arm group label: Treatment B

Intervention type: Drug

Intervention name: Lersivirine

Description: 1000 mg once daily for 10 days

Arm group label: Treatment C

Intervention type: Drug

Intervention name: Rifabutin

Description: 300 mg once daily for 10 days

Arm group label: Treatment C

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility Pfizer Investigational Site
Location Countries

Singapore

Verification Date

September 2010

Responsible Party

Name title: Director, Clinical Trial Disclosure Group

Organization: Pfizer, Inc.

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Treatment A

Arm group type: Active Comparator

Description: Lersivirine

Arm group label: Treatment B

Arm group type: Active Comparator

Description: Rifabutin

Arm group label: Treatment C

Arm group type: Experimental

Description: Lersivirine and Rifabutin

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov