Phase 1
Completed N=12
RDEA3170 and Allopurinol Combination Study in Gout Subjects
Source: ClinicalTrials.gov NCT02279641 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 1.13; 1.51; 12.8; 8.68 μg/mL
Summary
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
14.6; 14.5 | — |
| PRIMARY Time of Occurrence of Maximum Observed Concentration (Tmax) |
1.50; 1.25; 4.00; 3.50; 3.00; 3.00 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) |
120; 115 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) |
120; 115 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) |
1.06; 0.992; 43.2; 29.1; 11.5; 12.5 | — |
| PRIMARY Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24) |
66.8; 67.2 | — |
| PRIMARY Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24) |
120; 103; 15.1; 29.2; 9.28; 9.75 | — |
| PRIMARY Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine |
-50.5; -65.2; -43.0; 9.88; -21.6; -47.4 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
14.6; 14.5 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) |
120; 115 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) |
120; 115 | — |
| PRIMARY Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24) |
66.8; 67.2 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events |
2; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 and ≤ 10 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 an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
- Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
- Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is 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 (NCT02279641). 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. Informational only — not medical advice.