Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue

NCT00775294

Last updated date
Study Location
UNC Hospitals CTRC
Chapel Hill, North Carolina, 27514, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV/AIDS
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG for individuals >35yo and clinical laboratory tests).

- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >/=50 kg (110 lbs).

- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

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


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).


- Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other
procedure altering the gastrointestinal tract.


- Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and
have a clearly defined diagnosis of irritable bowel syndrome.


- Subject who is unwilling to refrain from any sexual activity including intercourse and
masturbation for 72 hours prior study visit Day 1 and until discharge from the study.


- Subject who is unwilling to refrain from rectal insertion of medical/recreation
devices and products and from receptive anal intercourse, for 72 hours before study
visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by
the investigators.


- History of febrile illness within 5 days prior to the first dose.


- Any condition possibly affecting drug absorption (eg, gastrectomy).


- A positive urine drug screen.


- A positive result for HIV.


- Active hepatitis B infection as defined by a positive Hepatitis B surface antigen
(HbsAg) OR a positive Hepatitis B core antibody with a negative Hepatitis B surface
antibody (HBsAb).


- Active hepatitis C infection as defined by anti-hepatitis C virus serology (as
determined by multi-antigen EIA) and detectable HCV RNA.


- A positive test for syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions) or
trichomonas at screening.


- History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150
mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.


- Participation in a clinical study within 4 months preceding the first dose of trial
medication.


- Participation in a rectal biopsy study in the 12 months preceding the first dose of
trial medication.


- Use of prescription or nonprescription drugs, vitamins and dietary supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of trial
medication. Herbal supplements must be discontinued 14 days prior to the first dose of
trial medication. As an exception, acetaminophen may be used at doses of

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.


- History of sensitivity to heparin or heparin-induced thrombocytopenia.


- Unwilling to abstain from alcohol use from 24 hours prior to the first dose of study
medication until after the follow-up visit.


- Unwilling to abstain from cigarette smoking completely during inpatient
pharmacokinetic visits and unwilling to limit smoking to a maximum of 5 cigarettes per
day from 24 hours prior to the start of the study until study completion.


- Unwilling or unable to comply with the dietary restrictions in regard to study drug
administration

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[email protected]

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HIV/AIDSStudy in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
NCT00775294
  1. Chapel Hill, North Carolina
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
Official Title  ICMJE A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Maraviroc Exposure in Blood, Saliva, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Maraviroc
Brief Summary This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Drug: Maraviroc
Healthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days)
Other Name: Selzentry
Study Arms  ICMJE Experimental: maraviroc
Single arm trial looking at the pharmacokinetics of maraviroc in healthy volunteers.
Intervention: Drug: Maraviroc
Publications * Brown KC, Patterson KB, Malone SA, Shaheen NJ, Prince HM, Dumond JB, Spacek MB, Heidt PE, Cohen MS, Kashuba AD. Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis. 2011 May 15;203(10):1484-90. doi: 10.1093/infdis/jir059.

*   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: February 3, 2010)
14
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2008)
12
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG for individuals >35yo and clinical laboratory tests).
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >/=50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract.
  • Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and have a clearly defined diagnosis of irritable bowel syndrome.
  • Subject who is unwilling to refrain from any sexual activity including intercourse and masturbation for 72 hours prior study visit Day 1 and until discharge from the study.
  • Subject who is unwilling to refrain from rectal insertion of medical/recreation devices and products and from receptive anal intercourse, for 72 hours before study visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by the investigators.
  • History of febrile illness within 5 days prior to the first dose.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • A positive result for HIV.
  • Active hepatitis B infection as defined by a positive Hepatitis B surface antigen (HbsAg) OR a positive Hepatitis B core antibody with a negative Hepatitis B surface antibody (HBsAb).
  • Active hepatitis C infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
  • A positive test for syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions) or trichomonas at screening.
  • History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.
  • Participation in a clinical study within 4 months preceding the first dose of trial medication.
  • Participation in a rectal biopsy study in the 12 months preceding the first dose of trial medication.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication. Herbal supplements must be discontinued 14 days prior to the first dose of trial medication. As an exception, acetaminophen may be used at doses of </= 1 g/day
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling to abstain from alcohol use from 24 hours prior to the first dose of study medication until after the follow-up visit.
  • Unwilling to abstain from cigarette smoking completely during inpatient pharmacokinetic visits and unwilling to limit smoking to a maximum of 5 cigarettes per day from 24 hours prior to the start of the study until study completion.
  • Unwilling or unable to comply with the dietary restrictions in regard to study drug administration
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775294
Other Study ID Numbers  ICMJE IRB 08-0418
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela Kashuba, UNC Eshelman School of Pharmacy
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Angela DM Kashuba, PharmDUNC Eshelman School of Pharmacy
Principal Investigator:Kristine B Patterson, MDUniversity of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP