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Clinical Trial Details

Trial ID: L5942
Source ID: NCT03296800
Associated Drug: Bexagliflozin
Title: Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03296800/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Probenecid|DRUG: Rifampin|DRUG: Verapamil
Outcome Measures: Primary: Cmax (Maximum Observed Plasma Concentration), Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA)., Up to 48 hours|Tmax (Time of Maximum Observed Plasma Concentration), Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA)., Up to 48 hours|T1/2 (Apparent Terminal Elimination Half-life), Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA)., Up to 48 hours|AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity), Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA)., Up to 48 hours | Secondary: Urinary Glucose Excretion 0-48 hr, Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics., 0 to 48 hours
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-09-27
Completion Date: 2017-12-06
Results First Posted: 2021-04-27
Last Update Posted: 2021-07-01
Locations: Covance Clinical Research Unit, Daytona Beach, Florida, 32117, United States
URL: https://clinicaltrials.gov/show/NCT03296800