Trial Outcomes & Findings for Bexagliflozin Drug/Drug Interaction Study With Digoxin (NCT NCT03197324)
NCT ID: NCT03197324
Last Updated: 2021-07-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Up to 120 hours
Results posted on
2021-07-23
Participant Flow
In this crossover study, the subject was to participate in 2 periods during which subjects received 2 treatments (A: Bexagliflozin co-administered with digoxin, B: Digoxin alone).
Participant milestones
| Measure |
Digoxin and Bexagliflozin Tablet, Then Digoxin Alone
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.
Subjects were discharged on Day 8.
On Day 19, subjects received a single oral dose of 0.5 mg digoxin and were discharged on Day 22.
|
Digoxin, Then Digoxin and Bexagliflozin
On Day 1, subjects received a single oral dose of 0.5 mg digoxin. Subjects were discharged on Day 6.
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. Subjects were discharged on Day 22.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Digoxin and Bexagliflozin Tablet, Then Digoxin Alone
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.
Subjects were discharged on Day 8.
On Day 19, subjects received a single oral dose of 0.5 mg digoxin and were discharged on Day 22.
|
Digoxin, Then Digoxin and Bexagliflozin
On Day 1, subjects received a single oral dose of 0.5 mg digoxin. Subjects were discharged on Day 6.
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. Subjects were discharged on Day 22.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Bexagliflozin Drug/Drug Interaction Study With Digoxin
Baseline characteristics by cohort
| Measure |
Bexagliflozin and Digoxin, Then Digoxin Alone
n=10 Participants
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
|
Digoxin Alone, Then Bexagliflozin and Digoxin
n=10 Participants
On Day 1, subjects received a single oral dose of 0.5 mg digoxin. 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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 6.37 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
73.6 kg
STANDARD_DEVIATION 11.28 • n=5 Participants
|
74.2 kg
STANDARD_DEVIATION 13.67 • n=7 Participants
|
73.9 kg
STANDARD_DEVIATION 12.20 • n=5 Participants
|
|
Height
|
167.1 cm
STANDARD_DEVIATION 8.44 • n=5 Participants
|
165.6 cm
STANDARD_DEVIATION 9.35 • n=7 Participants
|
166.4 cm
STANDARD_DEVIATION 8.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 120 hoursBlood 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
Outcome measures
| Measure |
Digoxin Alone
n=20 Participants
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Digoxin With Bexagliflozin
n=19 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
|---|---|---|
|
Digoxin Cmax (Maximum Observed Plasma Concentration)
|
2.315 ng/mL
Geometric Coefficient of Variation 28.8
|
2.301 ng/mL
Geometric Coefficient of Variation 40.9
|
PRIMARY outcome
Timeframe: Up to 120 hoursBlood 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
Outcome measures
| Measure |
Digoxin Alone
n=20 Participants
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Digoxin With Bexagliflozin
n=19 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
|---|---|---|
|
Digoxin Tmax (Time of Maximum Observed Plasma Concentration)
|
1.00 hours
Interval 1.0 to 2.0
|
1.00 hours
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Up to 120 hoursBlood 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
Outcome measures
| Measure |
Digoxin Alone
n=18 Participants
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Digoxin With Bexagliflozin
n=18 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
|---|---|---|
|
Digoxin T1/2 (Apparent Terminal Elimination Half-life)
|
34.3 hours
Geometric Coefficient of Variation 15.5
|
38.2 hours
Geometric Coefficient of Variation 15.7
|
PRIMARY outcome
Timeframe: Up to 120 hoursBlood 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
Outcome measures
| Measure |
Digoxin Alone
n=18 Participants
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Digoxin With Bexagliflozin
n=18 Participants
Bexagliflozin: Bexagliflozin tablets, 20 mg
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
|---|---|---|
|
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
|
35.558 h*ng/mL
Geometric Coefficient of Variation 16.6
|
37.805 h*ng/mL
Geometric Coefficient of Variation 27.5
|
Adverse Events
Digoxin Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Digoxin With Bexagliflozin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digoxin Alone
n=20 participants at risk
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
Digoxin With Bexagliflozin
n=19 participants at risk
Bexagliflozin: Bexagliflozin tablets, 20 mg
Digoxin: Two 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
General disorders
Fatigue
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
General disorders
Medical device site reaction
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
0.00%
0/19 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
0.00%
0/19 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 24 of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI does not have the right to publish trial results.
- Publication restrictions are in place
Restriction type: OTHER