NCT02956278

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 23, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

November 2, 2016

Results QC Date

May 27, 2019

Last Update Submit

June 9, 2020

Conditions

Chronic GoutHyperuricemia

Keywords

allopurinol

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Percent Change Uric Acid

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

    24 hours

Secondary Outcomes (1)

  • Oxypurinol AUC

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

Study Arms (3)

BCRP Q141K CC

PLACEBO COMPARATOR

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.

Drug: AllopurinolOther: Placebo

BCRP Q141K CA

EXPERIMENTAL

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.

Drug: AllopurinolOther: Placebo

BCRP Q141K AA

EXPERIMENTAL

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.

Drug: AllopurinolOther: Placebo

Interventions

AllopurinolDRUG
Also known as: Zyloprim, Aloprim
BCRP Q141K AABCRP Q141K CABCRP Q141K CC
PlaceboOTHER

lactose placebo pill

BCRP Q141K AABCRP Q141K CABCRP Q141K CC

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Open Medicine Institute

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Kathy Giacomini, PhD
Organization
University of California San Francisco
kathy.giacomini@ucsf.edu
415-514-4363

Study Officials

  • Kathleen Giacomini, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 7, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

June 23, 2020

Results First Posted

June 23, 2020

Record last verified: 2020-06

Locations

US(1)