Status:

WITHDRAWN

Absolute Bioavailability Study With Bexagliflozin

Lead Sponsor:

Theracos

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

MALE

18-55 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 16 2018

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03417076

Start Date

August 1 2018

End Date

September 16 2018

Last Update

September 30 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Clinical Research Site

Madison, Wisconsin, United States, 53704