Chronic GoutPhase 4NCT02956278
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
A Phase 4 study testing Allopurinol in people with Chronic Gout and Hyperuricemia, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Gout, Hyperuricemia
- What is being tested?
- Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Open Medicine Institute
Mountain View, California, 94040
About this study
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.
- Conditions
- Chronic Gout, Hyperuricemia
- Being tested
- Allopurinol, Placebo
- Keywords
- allopurinol
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Zyloprim, Aloprim
PlaceboOther
lactose placebo pill
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Allopurinol; Other: 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. Receives: Drug: Allopurinol; Other: 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. Receives: Drug: Allopurinol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxypurinol Renal Clearance
Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours
Measured: 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
Measured: 24 hours
Secondary outcomes (1)
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)
Measured: 24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic GoutStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Open Medicine Institute
- Responsible party
- Sponsor
- Investigators
- Kathleen Giacomini, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956278
- Sponsor's protocol ID
- 14-14550
- Other IDs
- R01DK103729
- Status last verified
- Jun 2020
- First submitted
- 2 Nov 2016
- Last updated
- 23 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
- ClinicalTrials.gov ID
- NCT02956278
- Acronym / sponsor ID
- 14-14550
- Conditions
- Chronic Gout, Hyperuricemia
- Keywords
- allopurinol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Open Medicine Institute
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCRP Q141K CC | Placebo comparator | Drug: Allopurinol, Other: PlaceboParticipants 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. |
| BCRP Q141K CA | Experimental | Drug: Allopurinol, Other: PlaceboParticipants 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. |
| BCRP Q141K AA | Experimental | Drug: Allopurinol, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: Zyloprim, Aloprim | Drug | BCRP Q141K AA, BCRP Q141K CA, BCRP Q141K CC |
| Placebolactose placebo pill | Other | BCRP Q141K AA, BCRP Q141K CA, BCRP Q141K CC |
Primary outcome
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
Percent Change Uric Acid
Time frame: 24 hours
Maximum percent change in uric acid after a single dose of allopurinol
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Giacomini, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Chronic Gout and Hyperuricemia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxypurinol Renal Clearance (time frame: 24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.