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OpenTrials
Completed

NCT Number: NCT02956278

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.

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Key information

Conditions

Chronic Gout Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Open Medicine Institute

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

Other names: Zyloprim, Aloprim

Placebo

Other

lactose placebo pill

Primary outcomes

  1. Oxypurinol Renal Clearance

    Time frame: 24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose)

    Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours

  2. Percent Change Uric Acid

    Time frame: 24 hours

    Maximum percent change in uric acid after a single dose of allopurinol

Secondary outcomes

  1. Oxypurinol AUC

    Time frame: 24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose)

    Area under the concentration time curve from 0-24 hours following a single dose of allopurinol (i.e. Day 1 of both protocols)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Open Medicine Institute

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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