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Clinical Trial Details

Trial ID: L6977
Source ID: NCT03167411
Associated Drug: Bexagliflozin
Title: Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03167411/results
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Exenatide Injection
Outcome Measures: Primary: Cmax (Maximum Observed Plasma Concentration), Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. Cmax was obtained directly from experimental observations., Up to 48 hrs|Tmax (Time of Maximum Observed Plasma Concentration), Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. Tmax was obtained directly from experimental observations., Up to 48 hrs|T1/2 (Apparent Terminal Elimination Half-life), Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. T1/2 was calculated as the natural log of 2 divided by the terminal phase rate constant., Up to 48 hrs|AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity), Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. AUC0-inf was calculated using the linear trapezoidal rule, using actual elapsed time values. If the actual time of sample collection was not available, the nominal time was used for the purpose of parameter estimation., Up to 48 hrs | Secondary: Urinary Glucose Excretion (UGE), Post-dose urine was collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36 h, and 36 to 48 h collections. After collection, the total volume of each batch and collection time was recorded. UGE, including UGE(t1-t2) and total 0-24 h and 0-48 h UGE were calculated. UGE(t1-t2) was derived from urine volume (Vt1-t2) multiplied by glucose concentration divided by 100., 0-48 hours
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-05-24
Completion Date: 2017-06-29
Results First Posted: 2021-05-28
Last Update Posted: 2021-05-28
Locations: Clinical Research Site, Evansville, Indiana, 47710, United States
URL: https://clinicaltrials.gov/show/NCT03167411