Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK103729 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Open Medicine Institute | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Giacomini, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Open Medicine Institute | Mountain View | California | 94040 | United States |
As the intent of the protocol was to characterize the effect of the genetic variant, data were collected and analyzed per genotype variant regardless of number of doses received.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BCRP Q141K CC | Participants that are homozygous reference for BCRP Q141K receive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours. |
| FG001 | BCRP Q141K CA | Participants that are heterozygous for the BCRP Q141K allele receive one 300 mg dose of allopurinol, with blood/urine collections up to 72 hours. |
| FG002 | BCRP Q141K AA | Participants homozygous for the BCRP Q141K allele receive one 300 mg dose of allopurinol with blood/urine collection for up to 72 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects were analyzed based on their BCRP Q141K genotype no matter which protocol (single or multiple dose) they participated in.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BCRP Q141K CC Genotype | All subjects that completed the protocol with the reference BCRP Q141K genotype (CC alleles) |
| BG001 | BCRP Q141K CA Genotype | All subjects that completed the protocol with the heterozygous BCRP Q141K genotype (CA alleles) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxypurinol Renal Clearance | Renal clearance as defined by amount excreted in 24 hours/AUC from 0-24 hours | Posted | Mean | Standard Deviation | L/hr | 24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose) |
|
During the course of the protocol and up to 72 hours following the final dose of allopurinol
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BCRP Q141K CC | Participants homozygous reference for BCRP Q141K receive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Giacomini, PhD | University of California San Francisco | 415-514-4363 | kathy.giacomini@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Single Dose Protocol | Nov 7, 2017 | Aug 15, 2019 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Multiple Dose Protocol | Sep 1, 2017 | Aug 15, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | lactose placebo pill |
|
| BG002 | BCRP Q141K AA Genotype | All subjects that completed the protocol with the homozygous BCRP Q141K genotype (AA alleles) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
All subjects that completed the protocol with the homozygous BCRP Q141K genotype (AA alleles) |
|
|
| Primary | Percent Change Uric Acid | Maximum percent change in uric acid after a single dose of allopurinol | Baseline and minimum SUA level after a single dose of allopurinol (i.e. Day 1) were used for the calculation (baseline-minimum)/baseline) | Posted | Mean | Standard Deviation | Percent Change from Baseline | 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) | Posted | Mean | Standard Deviation | mcg*hr/mL | 24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | BCRP Q141K CA | Participants heterozygous for BCRP Q141Kr eceive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | BCRP Q141K AA | Participants homozygous for BCRP Q141Kr eceive one 300 mg dose of allopurinol followed by blood/urine collection for up to 72 hours. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided