Antacid Interaction Study

NCT01982201 | Completed Phase 1

• 1 other identifier: RDEA594-130
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• PK profile of lesinurad from plasma and urine

  Plasma in terms of maximum observed concentration (Cmax), time of occurrence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), apparent terminal half-life (t½), renal clearance (CLR), and adverse event (Ae).

  Day 2 and Day 7

• PD profile of Lesinurad from serum and urine

  Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.

  Day 2 and Day 7

Secondary Outcomes (1)

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

  5 weeks

Study Arms (2)

Lesinurad and Tums

EXPERIMENTAL

Day 1: 240 mL water or 240 mL water and Tums Day 2: Lesinurad 400 mg or Lesinurad 400 mg and Tums; Day 6: 240 mL water and Tums or 240 mL water; Day 7: Lesinurad 400 mg and Tums or Lesinurad 400 mg

Drug: Lesinurad 400 mg; Drug: Tums 500 mg and 750 mg

Lesinurad and MINTOX

EXPERIMENTAL

Day 1: 240 mL water or 240 mL water and MINTOX ; Day 2: Lesinurad 400 mg or Lesinurad 400 mg and MINTOX; Day 6: 240 mL water and MINTOX or 240 mL water; Day 7: Lesinurad 400 mg and MINTOX or Lesinurad 400 mg

Drug: Lesinurad 400 mg; Drug: MINTOX 10 mL

Interventions

Lesinurad 400 mg DRUG

Lesinurad and MINTOX; Lesinurad and Tums

Tums 500 mg and 750 mg DRUG

Lesinurad and Tums

MINTOX 10 mL DRUG

Lesinurad and MINTOX

Eligibility Criteria

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

You may qualify if:

• Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
• Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

You may not qualify if:

• Subject has a history or suspicion of kidney stones.
• Subject has undergone major surgery within 3 months prior to Screening.
• Subject donated blood or experienced significant blood loss (\>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Interventions

lesinurad; Calcium Carbonate; aluminum hydroxide, magnesium hydroxide, simethicone drug combination

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• J. Hall

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

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: November 8, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)