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 range18 Years – 50 Years

SexALL

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)]

Number of participants with abnormal electrolytes

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

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 range18 Years – 50 Years

SexALL

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)]

Number of participants with abnormal electrolytes

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