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Trial · NCT02498652

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryCohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
PrimaryCohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
PrimaryCohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
PrimaryCohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
PrimaryCohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
PrimaryCohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
PrimaryCohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
PrimaryCohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
SecondaryMaximum Observed Concentration (Cmax)Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)Cmax of Allopurinol alone or in combination with RDEA3170
SecondaryTime of Occurrence of Maximum Observed Concentration (Tmax)Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)Tmax of Allopurinol alone or in combination with RDEA3170
SecondaryArea Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)AUC 0-24 of Allopurinol alone or in combination with RDEA3170
SecondaryArea Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)AUC last of Allopurinol alone or in combination with RDEA3170
SecondaryApparent Terminal Half-life (t1/2)Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)t1/2 of Allopurinol alone or in combination with RDEA3170
SecondaryNumber of Participants With Treatment-Emergent Adverse Events11 weeks

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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