Absolute Bioavailability Study With Bexagliflozin

Theracos

Status and phase: Withdrawn; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Bexagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03417076

THR-1442-C-446

Details and patient eligibility

About

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

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Bexagliflozin

Experimental group

Description:

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).

Treatment:

Drug: Bexagliflozin