Antacid Interaction Study

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MINTOX 10 mL; Drug: Tums 500 mg and 750 mg; Drug: Lesinurad 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982201

RDEA594-130

Details and patient eligibility

About

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.

Full description

In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Lesinurad and Tums

Experimental group

Description:

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

Treatment:

Drug: Tums 500 mg and 750 mg

Drug: Lesinurad 400 mg

Lesinurad and MINTOX

Experimental group

Description:

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

Treatment:

Drug: MINTOX 10 mL

Drug: Lesinurad 400 mg