Phase 2
N=41
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Gout
Bottom Line
View on ClinicalTrials.gov: NCT02498652 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
Jan 2018
Primary outcome: Primary: Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) — -40.2; -55.0; -56.8; -48.1 Maximum Percentage (%) Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RDEA3170 2.5 mg (Drug); allopurinol 300 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardea Biosciences, Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) |
-40.2; -55.0; -56.8; -48.1; -61.0; -69.5 | — |
| PRIMARY Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. |
5.8; 4.8; 4.0; 5.5; 4.6; 3.8 | — |
| PRIMARY Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) |
1065; 1827; 2633; 899; 958; 827 | — |
| PRIMARY Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) |
400; 517; 827; 310; 311; 305 | — |
| PRIMARY Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) |
-39.3; -54.4; -50.3; -57.8; -66.0; -73.2 | — |
| PRIMARY Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. |
6.2; 5.0; 4.6; 4.8; 4.1; 3.5 | — |
| PRIMARY Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) |
952; 2027; 2138; 812; 797; 816 | — |
| PRIMARY Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) |
372; 645; 681; 268; 267; 286 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
1.18; 2.43; 1.19; 1.16; 1.16; 1.14 | — |
| SECONDARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
1.50; 2.98; 2.02; 2.01; 2.49; 1.73 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) |
3.94; 11.0; 8.64; 4.06; 4.10; 3.81 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) |
3.70; 10.9; 4.25; 3.59; 3.76; 3.71 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) |
1.21; 1.47; 1.25; 1.20; 1.14; 1.17 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
6; 6 | — |
Summary
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.
Eligibility Criteria
Inclusion Criteria
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
- Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
- Subject has a Screening serum urate level ≥ 8 mg/dL.
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria
- Subject is unable to take colchicine for gout flare prophylaxis.
- Subject has a history or suspicion of kidney stones.
- Subject has any gastrointestinal disorder that affects motility and/or absorption.
- Subject had unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
- Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
- Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
- Subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
- Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Data sourced from ClinicalTrials.gov (NCT02498652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.