Lesinurad Interaction Study With Ranitidine

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-11-30

Brief Summary

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This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

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Detailed Description

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This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1 fasted

Day 1: Lesinurad 400 mg once daily (qd)

Day 5: Ranitidine 150 mg twice daily (bid)

Day 6: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad.

Day 7: Ranitidine 150 mg (bid)

Group Type EXPERIMENTAL

lesinurad 400 mg

Intervention Type DRUG

ranitidine 150 mg

Intervention Type DRUG

lesinurad 400 mg + ranitidine 150 mg

Intervention Type DRUG

Sequence 2 fasted

Day 1: Ranitidine 150 mg (bid)

Day 2: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad

Day 3: Ranitidine 150 mg (bid)

Day 7: Lesinurad 400 mg (qd)

Group Type EXPERIMENTAL

lesinurad 400 mg

Intervention Type DRUG

ranitidine 150 mg

Intervention Type DRUG

lesinurad 400 mg + ranitidine 150 mg

Intervention Type DRUG

Interventions

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lesinurad 400 mg

Intervention Type DRUG

ranitidine 150 mg

Intervention Type DRUG

lesinurad 400 mg + ranitidine 150 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Screening sUA value ≤ 7.0 mg/dL.
* 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 abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria

* history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
* history or suspicion of kidney stones.
* undergone major surgery within 3 months prior to Day 1.
* 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.
* inadequate venous access or unsuitable veins for repeated venipuncture.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes