CompletedPhase 2

A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA

United States36 participantsStarted 2017-10-25

Plain-language summary

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit

Who can participate

Age range18 Years – 99 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

✓. 18 to 65 years old
✓. Asymptomatic hyperuricemia (sUA \> 6.0 mg/dL)
✓. Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg
✓. Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

Exclusion criteria

✕. History of any clinically significant disease or disorder putting the patient at risk during the study, or influencing study results or ability to participate in the study
✕. eGFR\* \< 45 mL/minute/1.73 m2 at Screening.
✕. Type 2 diabetes mellitus with HbA1c \>8%.
✕. History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.
✕. Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.
✕. Positive test for hepatitis B, hepatitis C or HIV.
✕. Use of any medications in the 2 weeks preceding first administration of study drug.

What they're measuring

Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7

Timeframe: On Day -1 and Day 7 of each treatment period

Change From Baseline in Plasma Concentration (Cmax) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Trial details

NCT IDNCT03316131

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-19

Results submitted2019-06-27

View on ClinicalTrials.gov More Asymptomatic Hyperuricemia trials

Who can participate

Age range18 Years – 99 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

✓. 18 to 65 years old
✓. Asymptomatic hyperuricemia (sUA \> 6.0 mg/dL)
✓. Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg
✓. Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

Exclusion criteria

✕. History of any clinically significant disease or disorder putting the patient at risk during the study, or influencing study results or ability to participate in the study
✕. eGFR\* \< 45 mL/minute/1.73 m2 at Screening.
✕. Type 2 diabetes mellitus with HbA1c \>8%.
✕. History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.
✕. Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.
✕. Positive test for hepatitis B, hepatitis C or HIV.
✕. Use of any medications in the 2 weeks preceding first administration of study drug.

What they're measuring

Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7

Timeframe: On Day -1 and Day 7 of each treatment period

Change From Baseline in Plasma Concentration (Cmax) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)

Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7

Timeframe: On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)