Study S001454

A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of Exenatide on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin in Healthy Subjects

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03167411
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 20
Start: 2017-05-24
Primary completion: 2017-06-29
Lead sponsor: Theracos
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG:Bexagliflozin; DRUG:Exenatide Injection
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Cmax (Maximum Observed Plasma Concentration) [Up to 48 hrs]
Tmax (Time of Maximum Observed Plasma Concentration) [Up to 48 hrs]
T1/2 (Apparent Terminal Elimination Half-life) [Up to 48 hrs]
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) [Up to 48 hrs]

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