RDEA3170 and Allopurinol Combination Study in Gout Subjects

NCT02279641 | Completed Phase 1 Results

• 1 other identifier: RDEA3170-107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (12)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  22 days

• Time of Occurrence of Maximum Observed Concentration (Tmax)

  Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

  22 days

• 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

• 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

• Apparent Terminal Half-life (t1/2)

  t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

  22 days

• Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

  Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  22 days

• 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

• Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine

  22 days

• Maximum Observed Plasma Concentration (Cmax)

  Cmax of RDEA3170 Alone and In Combination with Allopurinol

  22 days

• 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

• 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

• Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

  Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol

  22 days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  22 days

Study Arms (2)

Sequence A

EXPERIMENTAL

RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd

Drug: RDEA3170 10 mg; Drug: allopurinol 300 mg

Sequence B

EXPERIMENTAL

allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd

Drug: RDEA3170 10 mg; Drug: allopurinol 300 mg

Interventions

RDEA3170 10 mg DRUG

Sequence A; Sequence B

allopurinol 300 mg DRUG

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Gout

Interventions

verinurad; Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jesse Hall, MD
• Organization: Study Information Center AstraZeneca

information.center@astrazeneca.com

+1 877-240-9479

Study Officials

• J. Hall, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: April 6, 2015
• Study Completion: September 11, 2015
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Locations

US (1)