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Absolute Bioavailability Study With Bexagliflozin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417076
Recruitment Status : Withdrawn (Sponsor decision to not initiate study due to sufficient bioavailability information)
First Posted : January 31, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

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
Type 2 Diabetes Mellitus Drug: Bexagliflozin Phase 1

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 16, 2018
Estimated Study Completion Date : September 16, 2018

Resource links provided by the National Library of Medicine


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 Name: EGT0001442, EGT0001474




Primary Outcome Measures :
  1. absolute bioavailability (Fp.o.) of bexagliflozin tablets [ Time Frame: 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 [ Time Frame: Up to 3 days ]
    adverse event as a measure of safety and tolerability of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417076


Locations
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United States, Wisconsin
Clinical Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Theracos
Investigators
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Study Director: Mason Freeman, M.D. Massachusetts General Hospital
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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT03417076    
Other Study ID Numbers: THR-1442-C-446
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases