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Completed

NCT Number: NCT01908257

Lesinurad Interaction Study With Ranitidine

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cypress, California, 90630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lesinurad 400 mg

Drug

ranitidine 150 mg

Drug

lesinurad 400 mg + ranitidine 150 mg

Drug

Primary outcomes

  1. PK profile of lesinurad from plasma and urine

    Time frame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)

    Profile in terms of Cmax, Tmax, AUC, CL/F, t1/2

    Cmax: maximum concentration; Tmax: time to reach max plasma concentration; AUC: area under the concentration-time curve; CL/F: total body clearance corrected for bioavailability; t1/2: apparent terminal half-life

Secondary outcomes

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

    Time frame: 6 weeks

  2. PD profile of lesinurad from serum

    Time frame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)

    Profile in terms of serum urate concentration

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2013
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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