Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	Change in Serum uric acid level	baseline and day 7 on each treatment	% change per treatment will be compared.
Primary	Change in Urinary excretion of uric acid	baseline and day 7 on each treatment	Timed urinary uric acid excretion per treatment will be compared
Primary	Renal clearance of uric acid	baseline and day 7 on each treatment	Renal clearance of uric acid will be calculated.
Primary	Fractional excretion of uric acid	baseline and day 7 on each treatment	Fractional excretion and renal clearance of uric acid will be calculated.
Secondary	Maximum plasma concentration (Cmax)	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment	To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Secondary	Time to reach maximum concentration (tmax)	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment	To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Secondary	Area under the concentration-time curve (AUC)	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment	To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Secondary	Half life (t1/2)	0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment	To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Secondary	Incidence of adverse events	Day 1 and Day 7 on each treatment	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Secondary	Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters	Day 1 and Day 8 on each treatment	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Secondary	Changes in vital signs and physical examination findings	Day 1 and Day 8 on each treatment	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Secondary	Incidence of adverse events	Day 42 of the study as follow up	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Secondary	Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters	Day 42 of the study as follow up	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Secondary	Changes in vital signs and physical examination findings	Day 42 of the study as follow up	To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Other	Change in Urinary pH	baseline and day 7 on each treatment	To evaluate the relationship between the doses of uralyt and urinary pH under the administration of RDEA3170.
Other	Deoxyribonucleic acid polymorphism	Day 1 of the study as randomization	To collect and store deoxyribonucleic acid (DNA) for future exploratory research.
Other	Change in Serum uric acid level	Baseline and day 7 on each treatment for cohort 6	% change per treatment will be compared.
Other	Change in Urinary excretion of uric acid	Baseline and day 7 on each treatment for cohort 6	Timed urinary uric acid excretion per treatment will be compared.
Other	Renal clearance of uric acid	Baseline and day 7 on each treatment for cohort 6	Renal clearance of uric acid will be calculated.
Other	Fractional excretion of uric acid	Baseline and day 7 on each treatment for cohort 6	Fractional excretion and renal clearance of uric acid will be calculated.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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