Lesinurad Interaction Study With Ranitidine

NCT01908257 | Completed Phase 1

• 1 other identifier: RDEA594-127
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• PK profile of lesinurad from plasma and urine

  Profile in terms of Cmax, Tmax, AUC, CL/F, t1/2 Cmax: maximum concentration; Tmax: time to reach max plasma concentration; AUC: area under the concentration-time curve; CL/F: total body clearance corrected for bioavailability; t1/2: apparent terminal half-life

  Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)

Secondary Outcomes (2)

• Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

  6 weeks

• PD profile of lesinurad from serum

  Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)

Study Arms (2)

Sequence 1 fasted

EXPERIMENTAL

Day 1: Lesinurad 400 mg once daily (qd) Day 5: Ranitidine 150 mg twice daily (bid) Day 6: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad. Day 7: Ranitidine 150 mg (bid)

Drug: lesinurad 400 mg; Drug: ranitidine 150 mg; Drug: lesinurad 400 mg + ranitidine 150 mg

Sequence 2 fasted

EXPERIMENTAL

Day 1: Ranitidine 150 mg (bid) Day 2: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad Day 3: Ranitidine 150 mg (bid) Day 7: Lesinurad 400 mg (qd)

Drug: lesinurad 400 mg; Drug: ranitidine 150 mg; Drug: lesinurad 400 mg + ranitidine 150 mg

Interventions

lesinurad 400 mg DRUG

Sequence 1 fasted; Sequence 2 fasted

ranitidine 150 mg DRUG

Sequence 1 fasted; Sequence 2 fasted

lesinurad 400 mg + ranitidine 150 mg DRUG

Sequence 1 fasted; Sequence 2 fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
• Screening sUA value ≤ 7.0 mg/dL.
• free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
• Subject has no clinically relevant abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

You may not qualify if:

• history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
• history or suspicion of kidney stones.
• undergone major surgery within 3 months prior to Day 1.
• donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
• inadequate venous access or unsuitable veins for repeated venipuncture.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

lesinurad; Ranitidine

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• S. Bradley, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)