A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

NCT ID: NCT01894776

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

HIV Infection; HIV-1 Infection; Mycobacterium Avium Complex (MAC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rifabutin

Intervention Type: DRUG

Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days

Maraviroc

Intervention Type: DRUG

Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days

Interventions

Rifabutin

Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days

Intervention Type: DRUG

Maraviroc

Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days

Intervention Type: DRUG

Other Intervention Names

Mycobutin, RFB; Celsentri, MVC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald W Cameron, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa

Locations

The Ottawa Hospital -General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 31647836 (View on PubMed)

Other Identifiers

2013 0080-01H

Identifier Type: -

Identifier Source: org_study_id