NCT03197324

Brief Summary

The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug is and how well the study drug is tolerated when taken with digoxin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2017

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 16, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

June 21, 2017

Results QC Date

May 21, 2021

Last Update Submit

July 21, 2021

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

  • Digoxin Cmax (Maximum Observed Plasma Concentration)

    Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin

    Up to 120 hours

  • Digoxin Tmax (Time of Maximum Observed Plasma Concentration)

    Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin

    Up to 120 hours

  • Digoxin T1/2 (Apparent Terminal Elimination Half-life)

    Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin

    Up to 120 hours

  • AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)

    Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin

    Up to 120 hours

Study Arms (2)

Digoxin Alone first, then Digoxin With Bexagliflozin

ACTIVE COMPARATOR
Drug: Digoxin

Digoxin with Bexagliflozin, then Digoxin alone

ACTIVE COMPARATOR
Drug: BexagliflozinDrug: Digoxin

Interventions

BexagliflozinDRUG

Bexagliflozin tablets, 20 mg

Also known as: EGT0001442, EGT0001474
Digoxin with Bexagliflozin, then Digoxin alone
DigoxinDRUG

2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)

Digoxin Alone first, then Digoxin With BexagliflozinDigoxin with Bexagliflozin, then Digoxin alone

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
  • Subjects who are non-smokers for at least 6 months prior to first dose
  • Subjects who are willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic

You may not qualify if:

  • Subjects with a clinically significant history of allergy to drugs or latex
  • Subjects with a history of alcohol or drug dependence in the past 12 months
  • Subjects who have donated a significant amount of blood in the past 2 months
  • Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
  • Subjects who had previously received digoxin or drugs of the same class, or SGLT2 inhibitors, in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance CRU

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

bexagliflozinDigoxin

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Results Point of Contact

Title
Albert Collinson, Ph.D.
Organization
Theracos Sub, LLC
acollinson@theracos.com
508-688-4221

Study Officials

  • Mason Freeman, M.D.

    Massachusetts General Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 23, 2017

Study Start

July 24, 2017

Primary Completion

September 17, 2017

Study Completion

September 17, 2017

Last Updated

July 23, 2021

Results First Posted

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)