Clinical trial NCT02279641: RDEA3170 and Allopurinol Combination Study in Gout Subjects
Official title: A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 22 days
measure: Time of Occurrence of Maximum Observed Concentration (Tmax)
timeFrame: 22 days
measure: Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
timeFrame: 22 days
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
timeFrame: 22 days
measure: Apparent Terminal Half-life (t1/2)
timeFrame: 22 days
measure: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
timeFrame: 22 days
measure: Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
timeFrame: 22 days
measure: Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
timeFrame: 22 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 22 days
measure: Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
timeFrame: 22 days
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
timeFrame: 22 days
measure: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
timeFrame: 22 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 22 days
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall, MD
role: STUDY_DIRECTOR
References: