- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197324
Bexagliflozin Drug/Drug Interaction Study With Digoxin
A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of Bexagliflozin on the Pharmacokinetics of Digoxin in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a phase 1, single center, open-label, two-period, two-treatment, crossover study to evaluate the effect of bexagliflozin tablets, 20 mg, on the pharmacokinetics (PK) of digoxin, 0.5 mg after co-administration in healthy subjects. Each subject was randomized into one of 2 treatment groups and participated in 2 treatment periods as outlined below. During the duration of the study, each subject received 8 single doses of bexagliflozin and 2 single doses of digoxin. Clinical laboratory tests and safety monitoring were conducted during Periods 1 and 2.
Group 1 - Period 1, Treatment A Subjects were admitted to the clinic on Day 0. Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, starting on Day 1 for 8 days, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 3. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (h) on Day 3, 24 h (Day 4), 48 h (Day 5), 72 h (Day 6), 96 h (Day 7), and 120 h (Day 8) after administration of digoxin. Subjects were discharged on Day 8.
Group 1 - Period 2, Treatment B Subjects were admitted to the clinic on Day 18. On Day 19, subjects received a single oral dose of 0.5 mg digoxin. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 h on Day 19, 24 h (Day 20), 48 h (Day 21), 72 h (Day 22), 96 h (Day 23), and 120 h (Day 24) after administration of digoxin. Subjects were discharged on Day 24.
Group 2 - Period 1, Treatment B Subjects were admitted to the clinic on Day 0. On Day 1, subjects received a single oral dose of 0.5 mg digoxin. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 h on Day 1, 24 h (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), and 120 h (Day 6) after administration of digoxin. Subjects were discharged on Day 6.
Group 2 - Period 2, Treatment A Subjects were admitted to the clinic on Day 14. Subjects received daily oral doses of a bexagliflozin tablet, 20 mg, for 8 days starting on Day 15, and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with bexagliflozin on Day 17. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 h on Day 17, 24 h (Day 18), 48 h (Day 19), 72 h (Day 20), 96 h (Day 21), and 120 h (Day 22) after administration of digoxin. Subjects were discharged on Day 22.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Covance CRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Digoxin Alone first, then Digoxin With Bexagliflozin
|
2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Active Comparator: Digoxin with Bexagliflozin, then Digoxin alone
|
Bexagliflozin tablets, 20 mg
Other Names:
2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digoxin Cmax (Maximum Observed Plasma Concentration)
Time Frame: Up to 120 hours
|
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)
Time Frame: Up to 120 hours
|
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)
Time Frame: Up to 120 hours
|
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)
Time Frame: Up to 120 hours
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Protective Agents
- Cardiotonic Agents
- Digoxin
- Bexagliflozin
Other Study ID Numbers
- THR-1442-C-443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type2 Diabetes Mellitus
-
Mathias Ried-LarsenUnknownDiabetes Mellitus, Type 2 | Type 2 Diabetes Mellitus | Type2 Diabetes | Type2 Diabetes MellitusDenmark
-
Sigrid Therapeutics ABCompletedOverweight | PreDiabetes | Prediabetic State | Type2 Diabetes | Obese | Type2 Diabetes Mellitus | Pre DiabetesFinland, Sweden
-
Hamad Medical CorporationQatar Computing Research Institute (QCRI); Droobi HealthUnknown
-
Andalas UniversityUniversiti Putra MalaysiaCompleted
-
Medstar Health Research InstituteCompletedType2 Diabetes Mellitus
-
Boryung Pharmaceutical Co., LtdRecruiting
-
Georgia Institute of TechnologyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Emory...CompletedType2 Diabetes MellitusUnited States
-
EMSWithdrawnType2 Diabetes Mellitus
-
TheracosCompletedType2 Diabetes MellitusUnited States
-
Chong Kun Dang PharmaceuticalUnknown
Clinical Trials on Bexagliflozin
-
TheracosCompletedType2 Diabetes MellitusUnited States, Japan
-
TheracosCompletedDiabetes Mellitus, Type 2United States, Japan
-
Yale UniversityCase Western Reserve UniversityRecruiting
-
TheracosCompletedType 2 Diabetes MellitusGermany, United States, Spain, Poland
-
TheracosCompletedEssential HypertensionUnited States
-
TheracosCompletedDiabetes MellitusUnited States
-
TheracosCompletedType2 Diabetes MellitusUnited States
-
TheracosCompletedType 2 Diabetes MellitusUnited States, Canada
-
Teva Pharmaceuticals USATeva Pharmaceuticals, Inc.Completed
-
TheracosCompletedType 2 Diabetes MellitusUnited States, Canada, Czechia, Denmark, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Taiwan