Cypress, California, 90630, United States
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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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
Drugranitidine 150 mg
Druglesinurad 400 mg + ranitidine 150 mg
DrugPrimary outcomes
-
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
-
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 6 weeks
-
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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