A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
NCT01894776
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc | |||
Official Title ICMJE | A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Maraviroc
Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily Interventions:
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 15 | |||
Original Estimated Enrollment ICMJE | 14 | |||
Actual Study Completion Date ICMJE | February 2015 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01894776 | |||
Other Study ID Numbers ICMJE | 2013 0080-01H | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ottawa Hospital Research Institute | |||
Study Sponsor ICMJE | Ottawa Hospital Research Institute | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Ottawa Hospital Research Institute | |||
Verification Date | February 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |