Antacid Interaction Study

Study identifier:RDEA594-130

ClinicalTrials.gov identifier:NCT01982201

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interaction Between Lesinurad and Calcium Carbonate and Aluminum/Magnesium Hydroxide-Containing Antacids in Healthy Adult Male Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Lesinurad 400 mg, Tums 500 mg and 750 mg, MINTOX 10 mL

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Nov 2013

Primary Completion Date: 01 Dec 2013

Study Completion Date: 01 Mar 2014

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 May 2014 by Ardea Biosciences, Inc.

Collaborators

Inclusion and exclusion criteria

Location

Kalamazoo, MI, United States, 49007

Arms	Assigned Interventions
Experimental: Lesinurad and Tums 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	-
Experimental: Lesinurad and MINTOX 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	-

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

V. Clauson

858.652.6549

Investigators

Principal Investigator

J. Hall

Ardea Biosciences, Inc.