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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925535
• Other study ID #: A5271043
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2009
• Last updated: September 17, 2010
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lersivirine
1000 mg once daily for 10 days
• Rifabutin
300 mg once daily for 10 days
• Lersivirine
1000 mg once daily for 10 days
• Rifabutin
300 mg once daily for 10 days

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h		20 days	No
Primary	Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h		20 days	No
Secondary	Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments		58 days	Yes

External Links

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