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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 : Completed
First Posted : November 6, 2016
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Placebo Comparator: BCRP Q141K CC
Participants that are homozygous reference for BCRP Q141K receive at least one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours post-dose.
Drug: Allopurinol
Other Names:
  • Zyloprim
  • Aloprim

Other: Placebo
lactose placebo pill

Experimental: BCRP Q141K CA
Participants that are heterozygous for the BCRP Q141K allele receive at least one 300 mg dose of allopurinol, with blood/urine collections up to 72 hours post-dose.
Drug: Allopurinol
Other Names:
  • Zyloprim
  • Aloprim

Other: Placebo
lactose placebo pill

Experimental: BCRP Q141K AA
Participants homozygous for the BCRP Q141K allele receive at least one 300 mg dose of allopurinol with blood/urine collection for up to 72 hours post-dose.
Drug: Allopurinol
Other Names:
  • Zyloprim
  • Aloprim

Other: Placebo
lactose placebo pill




Primary Outcome Measures :
  1. Oxypurinol Renal Clearance [ Time Frame: 24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose) ]
    Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours

  2. Percent Change Uric Acid [ Time Frame: 24 hours ]
    Maximum percent change in uric acid after a single dose of allopurinol


Secondary Outcome Measures :
  1. Oxypurinol AUC [ Time Frame: 24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose) ]
    Area under the concentration time curve from 0-24 hours following a single dose of allopurinol (i.e. Day 1 of both protocols)



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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
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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
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Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02956278    
Other Study ID Numbers: 14-14550
R01DK103729 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2016    Key Record Dates
Results First Posted: June 23, 2020
Last Update Posted: June 23, 2020
Last Verified: June 2020

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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:
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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