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WithdrawnNCT03417076Updated Sep 30, 2019

Absolute Bioavailability Study With Bexagliflozin

A Phase 1 interventional study of Bexagliflozin in Type 2 Diabetes Mellitus, sponsored by Theracos. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Theracos · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision to not initiate study due to sufficient bioavailability information
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DrugBexagliflozin

    Bexagliflozin tablets, 20 mg, and bexagliflozin by IV

    Also known as: EGT0001442, EGT0001474

05

What researchers measure

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)

    Time frame: Up to 48 hours

Secondary outcomes

  1. adverse events

    adverse event as a measure of safety and tolerability of treatment

    Time frame: Up to 3 days

06

Study locations

1 site
  • Clinical Research Site
    Madison, Wisconsin 53704, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03417076
Lead sponsor
Theracos
Responsible party
Sponsor
First posted
Jan 31, 2018
Start date
Aug 1, 2018 (estimated)
Primary completion
Sep 16, 2018 (estimated)
Completion
Sep 16, 2018 (estimated)
Last update
Sep 30, 2019

Study contacts

Mason Freeman, M.D.
study director · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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