Phase 4
Completed N=27
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Chronic Gout · Hyperuricemia
Source: ClinicalTrials.gov NCT02956278 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Oxypurinol Renal Clearance — 1.9; 1.4; 1.6 L/hr
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxypurinol Renal Clearance |
1.9; 1.4; 1.6 | — |
| PRIMARY Percent Change Uric Acid |
26.8; 23.8; 21.4 | — |
| SECONDARY Oxypurinol AUC |
95.9; 99.1; 108.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02956278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.