Absolute Bioavailability Study With Bexagliflozin

NCT ID: NCT03417076

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-09-16

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Bexagliflozin

Intervention Type DRUG

Bexagliflozin tablets, 20 mg, and bexagliflozin by IV

Interventions

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Bexagliflozin

Bexagliflozin tablets, 20 mg, and bexagliflozin by IV

Intervention Type DRUG

Other Intervention Names

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EGT0001442, EGT0001474

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Theracos

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mason Freeman, M.D.

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

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Clinical Research Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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THR-1442-C-446

Identifier Type: -

Identifier Source: org_study_id

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