Back to resultsAbsolute Bioavailability Study With Bexagliflozin
Primary Purpose
Type 2 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bexagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Clinical Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bexagliflozin
Arm 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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
adverse events
adverse event as a measure of safety and tolerability of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03417076
Brief Title
Absolute Bioavailability Study With Bexagliflozin
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision to not initiate study due to sufficient bioavailability information
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
September 16, 2018 (Anticipated)
Study Completion Date
September 16, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theracos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bexagliflozin
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Bexagliflozin
Other Intervention Name(s)
EGT0001442, EGT0001474
Intervention Description
Bexagliflozin tablets, 20 mg, and bexagliflozin by IV
Primary Outcome Measure Information:
Title
absolute bioavailability (Fp.o.) of bexagliflozin tablets
Description
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 Outcome Measure Information:
Title
adverse events
Description
adverse event as a measure of safety and tolerability of treatment
Time Frame
Up to 3 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mason Freeman, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Absolute Bioavailability Study With Bexagliflozin
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