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Absolute Bioavailability Study With Bexagliflozin

Sponsor
Theracos (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03417076
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
1.5
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Sep 16, 2018
Anticipated Study Completion Date :
Sep 16, 2018

Arms and Interventions

Arm Intervention/Treatment
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
Bexagliflozin tablets, 20 mg, and bexagliflozin by IV
Other Names:
  • EGT0001442, EGT0001474

    		•

    Outcome Measures

    Primary Outcome Measures

    1. absolute bioavailability (Fp.o.) of bexagliflozin tablets [Up to 48 hours]

      oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)

    Secondary Outcome Measures

    1. adverse events [Up to 3 days]

      adverse event as a measure of safety and tolerability of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Site Madison Wisconsin United States 53704

    Sponsors and Collaborators

    • Theracos

    Investigators

    • Study Director: Mason Freeman, M.D., Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Theracos
    ClinicalTrials.gov Identifier:
    NCT03417076
    Other Study ID Numbers:
    • THR-1442-C-446
    First Posted:
    Jan 31, 2018
    Last Update Posted:
    Sep 30, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Bexagliflozin

    Study Results

    No Results Posted as of Sep 30, 2019