Absolute Bioavailability Study With Bexagliflozin | NCT03417076

Studies
Absolute Bioavailability Study With Bexagliflozin

NCT03417076

Sponsor

Theracos

Status

Withdrawn

Last Update Posted

Sep 30, 2019Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

Bexagliflozin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to not initiate study due to sufficient bioavailability information

Expanded Access Info

Start Date

Aug 1, 2018Estimated

Primary Completion Date

Sep 16, 2018Estimated

Completion Date

Sep 16, 2018Estimated

First Submitted Date

Jan 24, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2019

Last Update Posted Date

Sep 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bexagliflozin	Drug	Bexagliflozin tablets, 20 mg, and bexagliflozin by IV	Bexagliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
adverse events	adverse event as a measure of safety and tolerability of treatment	Up to 3 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mason Freeman, M.D.	Massachusetts General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Site		Madison	Wisconsin	53704	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000705992	bexagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided