Trial Outcomes & Findings for Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects (NCT NCT02820298)
NCT ID: NCT02820298
Last Updated: 2021-06-10
Results Overview
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
Bexagliflozin Administered in Fed Condition, Then in Fasted Condition
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 and a second dose of bexagliflozin tablet in fasted state on day 8.
|
Bexagliflozin Administered in Fasted Condition, Then in Fed Condition
Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted state on day 1 and second dose of bexagliflozin tablet with a high-fat meal on day 8
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Bexagliflozin Administered in Fed Condition, Then in Fasted Condition
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 and a second dose of bexagliflozin tablet in fasted state on day 8.
|
Bexagliflozin Administered in Fasted Condition, Then in Fed Condition
Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted state on day 1 and second dose of bexagliflozin tablet with a high-fat meal on day 8
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Bexagliflozin Administered in Fed Condition, Then in Fasted Condition
n=13 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 and a second dose of bexagliflozin tablet in fasted state on day 8.
|
Bexagliflozin Administered in Fasted Condition, Then in Fed Condition
n=12 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted state on day 1 and second dose of bexagliflozin tablet with a high-fat meal on day 8
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Weight
|
75.05 kg
STANDARD_DEVIATION 14.65 • n=5 Participants
|
71.58 kg
STANDARD_DEVIATION 12.42 • n=7 Participants
|
73.38 kg
STANDARD_DEVIATION 13.46 • n=5 Participants
|
|
Height
|
173.6 cm
STANDARD_DEVIATION 9.3 • n=5 Participants
|
171.1 cm
STANDARD_DEVIATION 8.8 • n=7 Participants
|
172.4 cm
STANDARD_DEVIATION 9.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dosePopulation: The PK Population included all randomized subjects who received study drug and who had sufficient plasma bexagliflozin measurements to derive at least one PK parameter following dosing.
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Outcome measures
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
|
|---|---|---|
|
Cmax (Maximum Observed Plasma Concentration)
|
176.1 ng/mL
Geometric Coefficient of Variation 30.6
|
133.7 ng/mL
Geometric Coefficient of Variation 42.5
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dosePopulation: PK population
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Outcome measures
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
|
|---|---|---|
|
Tmax (Time of Maximum Observed Plasma Concentration)
|
5.0 hours
Interval 3.0 to 8.0
|
3.5 hours
Interval 2.0 to 5.0
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dosePopulation: PK population
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Outcome measures
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
|
|---|---|---|
|
AUC0-t (Area Under the Plasma Concentration-time Curve From Time 0 to t)
|
1222.7 h*ng/mL
Geometric Coefficient of Variation 26.8
|
1074.2 h*ng/mL
Geometric Coefficient of Variation 33.0
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dosePopulation: PK population
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Outcome measures
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
|
|---|---|---|
|
AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time 0 to ∞)
|
1258.7 ng*h/mL
Geometric Coefficient of Variation 5.8
|
1161.8 ng*h/mL
Geometric Coefficient of Variation 5.7
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dosePopulation: PK population
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Outcome measures
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin without a high-fat meal on day 8 after an overnight fast.
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 Participants
Subjects were dosed with bexagliflozin tablet, 20 mg, without a high-fat meal on day 1 after an overnight fast and a second dose of bexagliflozin with a high-fat meal on day 8 after an overnight fast.
|
|---|---|---|
|
T1/2 (Apparent Terminal Elimination Half-life)
|
10.1 hours
Geometric Coefficient of Variation 28.2
|
11.7 hours
Geometric Coefficient of Variation 38.0
|
Adverse Events
Bexagliflozin Tablet Dosed in Fed Condition
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Bexagliflozin Tablet Dosed in Fasted Condition
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bexagliflozin Tablet Dosed in Fed Condition
n=23 participants at risk
Subjects were dosed with bexagliflozin tablet, 20 mg, with a high-fat meal after an overnight fast
|
Bexagliflozin Tablet Dosed in Fasted Condition
n=24 participants at risk
Subjects were dosed with bexagliflozin tablet, 20 mg, in fasted condition after an overnight fast
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
4.2%
1/24 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
4.2%
1/24 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
|
Nervous system disorders
Parosmia
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
0.00%
0/24 • The adverse event data were collected from Day 0 up to Day 10
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
0.00%
0/24 • The adverse event data were collected from Day 0 up to Day 10
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
0.00%
0/24 • The adverse event data were collected from Day 0 up to Day 10
|
|
General disorders
Chest discomfort
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
0.00%
0/24 • The adverse event data were collected from Day 0 up to Day 10
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
4.3%
1/23 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
0.00%
0/24 • The adverse event data were collected from Day 0 up to Day 10
|
|
Reproductive system and breast disorders
Nasal congestion
|
0.00%
0/23 • The adverse event data were collected from Day 0 up to Day 10
|
4.2%
1/24 • Number of events 1 • The adverse event data were collected from Day 0 up to Day 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has no right to publish the results.
- Publication restrictions are in place
Restriction type: OTHER