The Ottawa Hospital -General Campus
Ottawa, Ontario, K1H 8L6, Canada
NCT Number: NCT01894776
Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Ottawa, Ontario, K1H 8L6, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
Other names: Mycobutin, RFB
Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
Other names: Celsentri, MVC
Time frame: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..
Maraviroc pharmacokinetics: Maraviroc only AUC (h*μg/L), Maraviroc + Rifabutin AUC (h*μg/L), Rifabutin AUC (h*μg/L), 25-O-desacetyl rifabutin AUC (h*μg/L).
Time frame: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..
Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L).
Time frame: 30 days
description and frequency of adverse events for all participants during the study.
Ottawa Hospital Research Institute
Other
Acronym: RIFAMARA
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