Official Title
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Phase
Phase 4Lead Sponsor
University of California, San FranciscoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Gout HyperuricemiaIntervention/Treatment
allopurinol ...Study Participants
27Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
lactose placebo pill
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.
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.
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.
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
| Event Type | Organ System | Event Term |
|---|
Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours
Maximum percent change in uric acid after a single dose of allopurinol
Area under the concentration time curve from 0-24 hours following a single dose of allopurinol (i.e. Day 1 of both protocols)
