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Clinical Trial Details

Trial ID: L4034
Source ID: NCT03557658
Associated Drug: Bexagliflozin
Title: Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03557658/results
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin
Outcome Measures: Primary: Cmax (Maximum Observed Plasma Concentration), Whole venous blood samples of 6mL were collected from a peripheral vein prior to dosing and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin. 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 6mL were collected from a peripheral vein prior to dosing and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin. 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 6mL were collected from a peripheral vein prior to dosing and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin. 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 6mL were collected from a peripheral vein prior to dosing and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA)., Up to 48 hours|Urinary Glucose Excretion 0-48 Hours, 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., 0-48 hours |
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-26
Completion Date: 2018-12-26
Results First Posted: 2021-05-07
Last Update Posted: 2021-06-03
Locations: Clinical Research Site 1, Boston, Massachusetts, 02114, United States|Clinical Research Site 2, Saint Paul, Minnesota, 55114, United States
URL: https://clinicaltrials.gov/show/NCT03557658