MedDataX Logo

Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

NCT ID: NCT02581553

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence AB

Day 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B)

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablets

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence BA

Day 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A).

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablets

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence CD

Day 1: lesinurad/allopurinol FDC tablets (Treatment C \[fasted\]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D \[fed\]).

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablets

Intervention Type DRUG

Sequence DC

Day 1: lesinurad/allopurinol FDC tablets (Treatment D \[fed\]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C \[fasted\]).

Group Type EXPERIMENTAL

lesinurad/allopurinol 200/300 FDC tablets

Intervention Type DRUG

Sequence EF

Day 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2)

Group Type EXPERIMENTAL

lesinurad 200 mg

Intervention Type DRUG

lesinurad/allopurinol 200/200 FDC tablets

Intervention Type DRUG

allopurinol 200 mg

Intervention Type DRUG

Sequence FE

Day 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E).

Group Type EXPERIMENTAL

lesinurad 200 mg

Intervention Type DRUG

lesinurad/allopurinol 200/200 FDC tablets

Intervention Type DRUG

allopurinol 200 mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lesinurad/allopurinol 200/300 FDC tablets

Intervention Type DRUG

lesinurad 200 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

lesinurad/allopurinol 200/200 FDC tablets

Intervention Type DRUG

allopurinol 200 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index ranging between 18 kg/m2 and 40 kg/m2.
* Screening serum urate level is ≤ 7.0 mg/dL.

Exclusion Criteria

* Asian subject who has a positive test for the HLA-B\*5801 allele.
* History or suspicion of kidney stones.
* Estimated creatinine clearance, as determined at Screening, of \< 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
* Undergone major surgery within 3 months prior to Screening.
* Donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.
* Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

N. Bhakta

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RDEA594-501

Identifier Type: -

Identifier Source: org_study_id