The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics

Hyperuricemia Clinical Trial

Official title:

The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956278
• Other study ID #: 14-14550
• Secondary ID: R01DK103729
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Gout
• Hyperuricemia

Intervention

Drug:
• Allopurinol

Other:
• Placebo
lactose placebo pill

Locations

Country	Name	City	State
United States	Open Medicine Institute	Mountain View	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Open Medicine Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxypurinol Renal Clearance	Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours	24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose)
Primary	Percent Change Uric Acid	Maximum percent change in uric acid after a single dose of allopurinol	24 hours
Secondary	Oxypurinol AUC	Area under the concentration time curve from 0-24 hours following a single dose of allopurinol (i.e. Day 1 of both protocols)	24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose)