Metformin and Furosemide Drug-Drug Interaction Study
Overview[ - collapse ][ - ]
Purpose | This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects. |
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Condition | Healthy |
Intervention | Drug: Lesinurad 400 mg Drug: Metformin 850 mg Drug: Furosemide 40 mg |
Phase | Phase 1 |
Sponsor | Ardea Biosciences, Inc. |
Responsible Party | Ardea Biosciences, Inc. |
ClinicalTrials.gov Identifier | NCT02028689 |
First Received | October 17, 2013 |
Last Updated | February 13, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 17, 2013 |
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Last Updated Date | February 13, 2014 |
Start Date | October 2013 |
Estimated Primary Completion Date | January 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [Time Frame: 5 weeks] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin and Furosemide Drug-Drug Interaction Study |
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Official Title | A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate Potential Pharmacokinetic Interaction Between Lesinurad and Metformin and Between Lesinurad and Furosemide in Health Adult Male Subjects |
Brief Summary | This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects. |
Detailed Description | Leinurad is a weak in vitro inhibitor of the hepatic transporter OCT1 and the renal transporters OAT1 and OAT3 (OAT1/3). To assess the clinical relevance of these in vitro findings, this clinical study will evaluate the effect of lesinurad on the PK of metformin (OCT1 substrate) and furosemide (OAT1/3 substrate). |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science |
Condition | Healthy |
Intervention | Drug: Lesinurad 400 mg Drug: Metformin 850 mg Drug: Furosemide 40 mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 23 |
Estimated Completion Date | January 2014 |
Estimated Primary Completion Date | November 2013 |
Eligibility Criteria | Inclusion Criteria: - Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2. - Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment. Exclusion Criteria: - Subject has a history or suspicion of kidney stones, prostatic hyperplasia, or urinary stricture. - Subject has undergone major surgery within 3 months prior to Screening. - Subject donated blood or experienced significant blood loss (>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening. - Subject has inadequate venous access or unsuitable veins for repeated venipuncture. |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02028689 |
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Other Study ID Numbers | RDEA594-128 |
Has Data Monitoring Committee | No |
Information Provided By | Ardea Biosciences, Inc. |
Study Sponsor | Ardea Biosciences, Inc. |
Collaborators | Not Provided |
Investigators | Study Director: S. Bradley Ardea Biosciences, Inc. |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
United States, Michigan | Kalamazoo, Michigan, United States, 49007 |
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