ClinicalTrials.gov
ClinicalTrials.gov Menu

Lesinurad Interaction Study With Ranitidine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01908257
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: lesinurad 400 mg Drug: ranitidine 150 mg Drug: lesinurad 400 mg + ranitidine 150 mg Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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)

Drug: lesinurad 400 mg Drug: ranitidine 150 mg Drug: lesinurad 400 mg + ranitidine 150 mg
Experimental: 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)

Drug: lesinurad 400 mg Drug: ranitidine 150 mg Drug: lesinurad 400 mg + ranitidine 150 mg



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908257


Locations
United States, California
Cypress, California, United States, 90630
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: S. Bradley, MD Ardea Biosciences, Inc.

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01908257     History of Changes
Other Study ID Numbers: RDEA594-127
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Lesinurad
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents