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

• ClinicalTrials.gov Identifier: NCT00925535
• Recruitment Status: Completed
• First Posted: June 22, 2009
• Last Update Posted: September 21, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: June 19, 2009
• First Posted Date: June 22, 2009
• Last Update Posted Date: September 21, 2010
• Study Start Date: May 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2009)

• Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]
• Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 19, 2009): Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments [ Time Frame: 58 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Volunteers

Intervention

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

Study Arms

• Active Comparator: Treatment A
  Lersivirine
  Intervention: Drug: Lersivirine
• Active Comparator: Treatment B
  Rifabutin
  Intervention: Drug: Rifabutin
• Experimental: Treatment C
  Lersivirine and Rifabutin
  Interventions:

  • Drug: Lersivirine
  • Drug: Rifabutin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 19, 2009): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00925535
• Other Study ID Numbers: A5271043
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: September 2010