NCT01884272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

June 18, 2013

Last Update Submit

November 6, 2013

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

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

    13 weeks

Study Arms (2)

Lesinurad 400 mg and naproxen 250 mg

EXPERIMENTAL

Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14.

Drug: lesinurad 400 mgDrug: naproxen 250 mg

Lesinurad 400 mg and indomethacin 25 mg

ACTIVE COMPARATOR

Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14.

Drug: lesinurad 400 mgDrug: indomethacin 25 mg

Interventions

lesinurad 400 mgDRUG
Lesinurad 400 mg and indomethacin 25 mgLesinurad 400 mg and naproxen 250 mg
naproxen 250 mgDRUG
Lesinurad 400 mg and naproxen 250 mg
indomethacin 25 mgDRUG
Lesinurad 400 mg and indomethacin 25 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Gout

Interventions

lesinuradNaproxenIndomethacin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • S Bradley, MD

    Ardea Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 24, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

US(1)