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Report for Clinical Trial NCT02956278

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics

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.

NCT02956278 Chronic Gout Hyperuricemia
MeSH:Hyperuricemia
HPO:Hyperuricemia

2 Interventions

Name: Allopurinol

Type: Drug
Group Labels: 1

Allopurinol

Name: Placebo

Description: lactose placebo pill
Type: Other
Group Labels: 1

Placebo


Primary Outcomes

Measure: Allopurinol/Oxypurinol Renal Clearance

Time: as determined by blood/urine levels taken over the course of one week

Measure: Uric Acid Levels

Time: as determined by blood/urine levels taken over the course of one week

Secondary Outcomes

Measure: Allopurinol/Oxypurinol steady state concentrations

Time: as determined by blood/urine levels taken over the course of one week

Measure: Allopurinol/Oxypurinol AUC

Time: as determined by blood levels taken over the course of one week

Purpose: Basic Science

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs2231142

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 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 Chronic Gout Hyperuricemia Hyperuricemia null



HPO Nodes


HPO: