Clinical trial NCT01894776: A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Official title: A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
HIV-1 Infection
Mycobacterium Avium Complex (MAC)
Keywords: healthy volunteers
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-07-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Able and willing to sign informed consent prior to any study-related activities.
* Male or female participants between 18 and 65 years of age inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Healthy, i.e. not suffering from an acute or chronic illness and not using medications.
* Acceptable medical history, physical examination, and 12-lead ECG at screening.
* Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
* Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
* Willingness to abstain from alcohol use for 3 days prior to and during the study.
* Participant must practice a reliable method of birth control while they are participating in the study; for instance an intrauterine device (IUD), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post menopausal for at least one year.

Exclusion Criteria:

* Have serological evidence of exposure to HIV
* Female patients of childbearing potential who has a positive urine pregnancy test at screening
* Participants not willing to use a reliable method of barrier contraception during the study.
* Is breastfeeding.
* Inability to adhere to protocol.
* Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
* Participants taking oral contraceptive medications.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Patients may be excluded from the study for other reasons, at the investigator's discretion.

Primary outcomes:
measure: Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
timeFrame: 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..
measure: Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
timeFrame: 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..
Secondary outcomes:
measure: Safety/Tolerability of the Treatments
timeFrame: 30 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital -General Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa
name: Donald W Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghannad M, Dennehy M, la Porte C, Seguin I, Tardiff D, Mallick R, Sabri E, Zhang G, Kanji S, Cameron DW. A drug interaction study investigating the effect of Rifabutin on the pharmacokinetics of Maraviroc in healthy subjects. PLoS One. 2019 Oct 24;14(10):e0223969. doi: 10.1371/journal.pone.0223969. eCollection 2019.