Antacid Interaction Study

Sponsor

Ardea Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01982201

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lesinurad 400 mg Drug: Tums 500 mg and 750 mg Drug: MINTOX 10 mL	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Lesinurad 400 mg Drug: Tums 500 mg and 750 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	Drug: Lesinurad 400 mg Drug: MINTOX 10 mL

Arm

Intervention/Treatment

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

Drug: Lesinurad 400 mg

Drug: Tums 500 mg and 750 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

Drug: Lesinurad 400 mg

Drug: MINTOX 10 mL

Outcome Measures

Primary Outcome Measures

PK profile of lesinurad from plasma and urine [Day 2 and Day 7]
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).
PD profile of Lesinurad from serum and urine [Day 2 and Day 7]
Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.

Secondary Outcome Measures

Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kalamazoo	Michigan	United States	49007

Sponsors and Collaborators

Ardea Biosciences, Inc.

Investigators

Study Director: J. Hall, Ardea Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ardea Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT01982201

Other Study ID Numbers:

RDEA594-130

First Posted:

Nov 13, 2013

Last Update Posted:

May 20, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Lesinurad

Study Results

No Results Posted as of May 20, 2014