CompletedPhase 1

A Study to Assess the Safety and Pharmacokinetics of Verinurad and Allopurinol in Asian and Chinese Subjects

United States6 participantsStarted 2019-01-16

Plain-language summary

This is a randomized, placebo controlled, double-blind study with two separate cohorts to assess safety, tolerability and pharmacokinetics of verinurad and allopurinol in healthy subjects. In cohort 1, twelve Asian subjects will be treated with allopurinol 300mg for 7 days followed by either allopurinol 300mg and verinurad 24mg or matching placebo for 7 days. In Cohort 2, nine Chinese subjects will be treated with allopurinol 300mg for 7 days followed by allopurinol 300mg and verinurad 12mg administered on 7 out of 8 days.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
. OR if of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy for the entire study period.

Exclusion criteria

. Alanine aminotransferase (ALT) \>1.5 x upper limit of normal (ULN);
. Aspartate aminotransferase (AST) \>1.5 x ULN;
. Bilirubin (total) \> 1.5 x ULN; and
. Gamma glutamyl transpeptidase (GGT) \>1.5 x ULN. If any these tests are out-of-range the test can be repeated once at the Screening Visit at the discretion of the Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events

Timeframe: From screening up to Follow-up visit/Early discontinuation visit (EDV) (7-14 Days Post-last PK Sample)

Number of participants with abnormal findings in electrocardiography (ECG)

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal pulse rate

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal hematology

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal blood pressure (systolic and diastolic)

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)]

Number of participants with abnormal physical examination

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK sample)]

Trial details

NCT IDNCT03836599

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-26

View on ClinicalTrials.gov More Chronic Kidney Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
. OR if of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy for the entire study period.

Exclusion criteria

. Alanine aminotransferase (ALT) \>1.5 x upper limit of normal (ULN);
. Aspartate aminotransferase (AST) \>1.5 x ULN;
. Bilirubin (total) \> 1.5 x ULN; and
. Gamma glutamyl transpeptidase (GGT) \>1.5 x ULN. If any these tests are out-of-range the test can be repeated once at the Screening Visit at the discretion of the Investigator.

What they're measuring

Number of participants with adverse events

Timeframe: From screening up to Follow-up visit/Early discontinuation visit (EDV) (7-14 Days Post-last PK Sample)

Number of participants with abnormal findings in electrocardiography (ECG)

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal pulse rate

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal hematology

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)

Number of participants with abnormal blood pressure (systolic and diastolic)

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK Sample)]

Number of participants with abnormal physical examination

Timeframe: From screening up to Follow-up visit/EDV (7-14 Days Post-last PK sample)]