RDEA3170 and Allopurinol Combination Study in Gout Subjects

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279641
• Other study ID #: RDEA3170-107
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2014
• Last updated: December 19, 2017
• Start date: November 1, 2014
• Est. completion date: September 11, 2015

Study information

• Verified date: December 2017
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 11, 2015
• Est. primary completion date: April 6, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• RDEA3170 10 mg

• allopurinol 300 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170	22 days
Primary	Time of Occurrence of Maximum Observed Concentration (Tmax)	Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination	22 days
Primary	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170	22 days
Primary	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170	22 days
Primary	Apparent Terminal Half-life (t1/2)	t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination	22 days
Primary	Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)	Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170	22 days
Primary	Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)	CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination	22 days
Primary	Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine		22 days
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax of RDEA3170 Alone and In Combination with Allopurinol	22 days
Primary	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol	22 days
Primary	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	AUC last of RDEA3170 Alone and In Combination with Allopurinol	22 days
Primary	Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)	Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol	22 days
Secondary	Incidence of Treatment-Emergent Adverse Events		22 days