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

NCT01894776

Last updated date
Study Location
The Ottawa Hospital -General Campus
Ottawa, Ontario, K1H 8L6, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infection, HIV-1 Infection, Mycobacterium Avium Complex (MAC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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HIV Infection, HIV-1 Infection, Mycobacterium Avium Complex (MAC)A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
NCT01894776
  1. Ottawa, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • HIV Infection
  • HIV-1 Infection
  • Mycobacterium Avium Complex (MAC)
Intervention  ICMJE
  • Drug: Rifabutin
    Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
    Other Name: Mycobutin, RFB
  • Drug: Maraviroc
    Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
    Other Name: Celsentri, MVC
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:
  • Drug: Rifabutin
  • Drug: Maraviroc
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
 (submitted: March 2, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2013)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Donald W Cameron, MDThe Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa
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