Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956278
Recruitment Status : Active, not recruiting
First Posted : November 7, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Open Medicine Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.

Condition or disease Intervention/treatment Phase
Chronic Gout Hyperuricemia Drug: Allopurinol Other: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will take a placebo and provide blood/urine samples for 24 hours
Other: Placebo
lactose placebo pill

Experimental: Allopurinol
Subjects will take allopurinol for 6 days. On day 1 and 6, subjects will provide blood and urine samples for 24 hours. Subjects will provide additional blood samples on days 7 and 8.
Drug: Allopurinol



Primary Outcome Measures :
  1. Allopurinol/Oxypurinol Renal Clearance [ Time Frame: as determined by blood/urine levels taken over the course of one week ]
  2. Uric Acid Levels [ Time Frame: as determined by blood/urine levels taken over the course of one week ]

Secondary Outcome Measures :
  1. Allopurinol/Oxypurinol steady state concentrations [ Time Frame: as determined by blood/urine levels taken over the course of one week ]
  2. Allopurinol/Oxypurinol AUC [ Time Frame: as determined by blood levels taken over the course of one week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • self-identified as Asian/European ancestry
  • generally healthy with approved lab values for CBC,HFP,RFP, and uric acid
  • Subjects with the ABCG2 genotype, homozygous, heterozygous or homozygous for the major allele of rs2231142 will be recruited

Exclusion Criteria:

  • vascular disease
  • renal impairment
  • medications/supplements that affect uric acid levels
  • pregnant or lactating women
  • prior history of allergic reaction to allopurinol or testing positive for HLA-B*5801 allele
  • risk of urinary or gastric retention or narrow-angle glaucoma
  • impaired hepatic function
  • evidence of anemia
  • evidence or diagnosis of congestive heart failure
  • smokers
  • subjects with a mutation other than rs2231142 in the ABCG2 genotype
  • subjects taking hormonal contraceptives or other hormonal medications
  • evidence of recreational drug use as determined by questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956278


Locations
Layout table for location information
United States, California
Open Medicine Institute
Mountain View, California, United States, 94040
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Open Medicine Institute
Investigators
Layout table for investigator information
Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02956278     History of Changes
Other Study ID Numbers: 14-14550
R01DK103729 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
allopurinol
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperuricemia
Pathologic Processes
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs