Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGBexagliflozin
Bexagliflozin tablets, 20 mg, and bexagliflozin by IV
Sponsors
Theracos
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| adverse events | Up to 3 days | adverse event as a measure of safety and tolerability of treatment |
Countries
United States
Outcome results
None listed