Absolute Bioavailability Study With Bexagliflozin

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

The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Bexagliflozin

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Bexagliflozin; Bexagliflozin tablets, 20 mg, and bexagliflozin by IV; Other Names: EGT0001442, EGT0001474

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	adverse event as a measure of safety and tolerability of treatment	Up to 3 days

Collaborators and Investigators

• Sponsor: Theracos

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): September 16, 2018
• Study Completion (Anticipated): September 16, 2018

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Bexagliflozin
• Other Study ID Numbers: THR-1442-C-446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No