The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
NCT ID: NCT02956278
Last Updated: 2020-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2016-11-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
Allopurinol
Placebo
lactose placebo pill
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.
Allopurinol
Placebo
lactose placebo pill
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.
Allopurinol
Placebo
lactose placebo pill
Interventions
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Allopurinol
Placebo
lactose placebo pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Open Medicine Institute
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kathleen Giacomini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Open Medicine Institute
Mountain View, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Single Dose Protocol
Document Type: Study Protocol and Statistical Analysis Plan: Multiple Dose Protocol
Other Identifiers
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14-14550
Identifier Type: -
Identifier Source: org_study_id
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