NSAID Drug Interaction Study

Gout Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884272
• Other study ID #: RDEA594-126
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2013
• Last updated: November 6, 2013
• Start date: June 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.

Description:

Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject has a body weight = 50 kg (110 lbs) and a body mass index (BMI) = 18 and = 30 kg/m2.

• Subject is 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 abnormalities in vital signs, ECG, physical examination or safety laboratory values.

Exclusion Criteria:

• Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.

• Subject has a history or suspicion of kidney stones.

• Subject has a history of asthma.

• Subject has undergone major surgery within 3 months prior to Day 1.

• Subject has 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.

• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• lesinurad 400 mg

• naproxen 250 mg

• indomethacin 25 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile of lesinurad from plasma and urine	Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life	Day 1, Day 6 (urine only), Day 7, Day 14	No
Primary	PK profile of naproxen and indomethacin from plasma and urine	Profile in terms of AUC, Tmax, Cmax, and t1/2	Day 1, Day 6 (urine only), Day 7, Day 14	No
Secondary	Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters		13 weeks	Yes