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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00925535
First received: June 19, 2009
Last updated: September 17, 2010
Last verified: September 2010
History of Changes

June 19, 2009
September 17, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
  • Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00925535 on ClinicalTrials.gov Archive Site
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments [ Time Frame: 58 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Lersivirine
    1000 mg once daily for 10 days
  • Drug: Rifabutin
    300 mg once daily for 10 days
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00925535
A5271043
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP