NCT03417076

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2018

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

January 24, 2018

Last Update Submit

September 27, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • adverse events

    Up to 3 days

Study Arms (1)

Bexagliflozin

EXPERIMENTAL

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

Interventions

BexagliflozinDRUG

Bexagliflozin tablets, 20 mg, and bexagliflozin by IV

Also known as: EGT0001442, EGT0001474
Bexagliflozin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mason Freeman, M.D.

    Massachusetts General Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

August 1, 2018

Primary Completion

September 16, 2018

Study Completion

September 16, 2018

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)