Absolute Bioavailability Study With Bexagliflozin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03417076
• Other study ID #: THR-1442-C-446
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 1, 2018
• Est. completion date: September 16, 2018

Study information

• Verified date: September 2019
• Source: Theracos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 16, 2018
• Est. primary completion date: September 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Bexagliflozin
Bexagliflozin tablets, 20 mg, and bexagliflozin by IV

Locations

Country	Name	City	State
United States	Clinical Research Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Theracos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute bioavailability (Fp.o.) of bexagliflozin tablets	oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)	Up to 48 hours
Secondary	adverse events	adverse event as a measure of safety and tolerability of treatment	Up to 3 days