Absolute Bioavailability Study With Bexagliflozin
- Registration Number
- NCT03417076
- Lead Sponsor
- Theracos
- Brief Summary
The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- no nicotine and tobacco consumption in the past 3 months
- willing and able to be confined to the clinical research facility as required by the protocol
Exclusion Criteria
- clinically significant history of allergy to drugs or latex
- history of alcohol or drug dependence in the past 12 months.
- donation of a significant amount of blood in the past 2 months
- willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
- exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bexagliflozin Bexagliflozin Each subject will receive a single oral dose of bexagliflozin tablets, 20 mg, followed by a single IV dosing of \< 30 ug 14C-bexagliflozin in 0.9% saline solution).
- Primary Outcome Measures
Name Time Method absolute bioavailability (Fp.o.) of bexagliflozin tablets Up to 48 hours oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)
- Secondary Outcome Measures
Name Time Method adverse events Up to 3 days adverse event as a measure of safety and tolerability of treatment
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Madison, Wisconsin, United States