Trial Outcomes & Findings for Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers (NCT NCT04932655)
NCT ID: NCT04932655
Last Updated: 2023-08-22
Results Overview
The maximum concentration determined directly from individual concentration-time data
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Sequence A
This arm received Phase 2 tablet fasted (Period 1), Phase 3 tablet fasted (Period 2), Phase 3 tablet after a high-fat meal (Period 3), and Phase 3 tablet after a low-fat meal (Period 4).
|
Sequence B
This arm received Phase 3 tablet after a low-fat meal (Period 1), Phase 2 tablet fasted (Period 2), Phase 3 tablet fasted (Period 3), and Phase 3 tablet after a high-fat meal (Period 4).
|
Sequence C
This arm received Phase 3 tablet fasted (Period 1), Phase 3 tablet after a high-fat meal (Period 2), Phase 3 tablet after a low-fat meal (Period 3), and Phase 2 tablet fasted (Period 4).
|
Sequence D
This arm received Phase 3 tablet after a high-fat meal (Period 1), Phase 3 tablet after a low-fat meal (Period 2), Phase 2 tablet fasted (Period 3), and Phase 3 tablet fasted (Period 4).
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
6
|
6
|
6
|
6
|
|
Period 4
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Sequence A
n=6 Participants
This arm received Phase 2 tablet fasted (Period 1), Phase 3 tablet fasted (Period 2), Phase 3 tablet after a high-fat meal (Period 3), and Phase 3 tablet after a low-fat meal (Period 4).
|
Sequence B
n=6 Participants
This arm received Phase 3 tablet after a low-fat meal (Period 1), Phase 2 tablet fasted (Period 2), Phase 3 tablet fasted (Period 3), and Phase 3 tablet after a high-fat meal (Period 4).
|
Sequence C
n=6 Participants
This arm received Phase 3 tablet fasted (Period 1), Phase 3 tablet after a high-fat meal (Period 2), Phase 3 tablet after a low-fat meal (Period 3), and Phase 2 tablet fasted (Period 4).
|
Sequence D
n=6 Participants
This arm received Phase 3 tablet after a high-fat meal (Period 1), Phase 3 tablet after a low-fat meal (Period 2), Phase 2 tablet fasted (Period 3), and Phase 3 tablet fasted (Period 4).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 2.14 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 3.52 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 4.18 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 7.09 • n=4 Participants
|
33.7 years
STANDARD_DEVIATION 5.23 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Height
|
172.08 cm
STANDARD_DEVIATION 10.24 • n=5 Participants
|
174.95 cm
STANDARD_DEVIATION 6.37 • n=7 Participants
|
168.70 cm
STANDARD_DEVIATION 10.65 • n=5 Participants
|
173.62 cm
STANDARD_DEVIATION 14.43 • n=4 Participants
|
172.34 cm
STANDARD_DEVIATION 10.36 • n=21 Participants
|
|
Weight
|
79.25 Kg
STANDARD_DEVIATION 11.70 • n=5 Participants
|
75.77 Kg
STANDARD_DEVIATION 14.63 • n=7 Participants
|
69.78 Kg
STANDARD_DEVIATION 15.92 • n=5 Participants
|
80.58 Kg
STANDARD_DEVIATION 18.70 • n=4 Participants
|
76.35 Kg
STANDARD_DEVIATION 15.02 • n=21 Participants
|
|
BMI
|
26.63 Kg/m^2
STANDARD_DEVIATION 1.85 • n=5 Participants
|
24.62 Kg/m^2
STANDARD_DEVIATION 3.49 • n=7 Participants
|
24.35 Kg/m^2
STANDARD_DEVIATION 3.51 • n=5 Participants
|
26.45 Kg/m^2
STANDARD_DEVIATION 2.55 • n=4 Participants
|
25.51 Kg/m^2
STANDARD_DEVIATION 2.93 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hoursThe maximum concentration determined directly from individual concentration-time data
Outcome measures
| Measure |
Fasted Phase 3 Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken in a fasted state.
|
Phase 3 High-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a high-fat meal.
|
Phase 3 Low-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a low-fat meal.
|
Fasted Phase 2 Simufilam
n=24 Participants
All subjects after taking the Phase 2 simufilam oral tablet in a fasted state.
|
|---|---|---|---|---|
|
Cmax
|
698 ng/mL
Standard Deviation 190
|
715 ng/mL
Standard Deviation 156
|
755 ng/mL
Standard Deviation 149
|
680 ng/mL
Standard Deviation 193
|
PRIMARY outcome
Timeframe: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hoursArea under the curve to the time of the last quantifiable concentration, calculated using the linear trapezoidal method
Outcome measures
| Measure |
Fasted Phase 3 Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken in a fasted state.
|
Phase 3 High-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a high-fat meal.
|
Phase 3 Low-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a low-fat meal.
|
Fasted Phase 2 Simufilam
n=24 Participants
All subjects after taking the Phase 2 simufilam oral tablet in a fasted state.
|
|---|---|---|---|---|
|
AUClast
|
3890 h*ng/mL
Standard Deviation 1050
|
3810 h*ng/mL
Standard Deviation 951
|
3830 h*ng/mL
Standard Deviation 971
|
3860 h*ng/mL
Standard Deviation 978
|
PRIMARY outcome
Timeframe: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hoursArea under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/λz
Outcome measures
| Measure |
Fasted Phase 3 Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken in a fasted state.
|
Phase 3 High-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a high-fat meal.
|
Phase 3 Low-fat Fed Simufilam
n=24 Participants
All subjects following Phase 3 simufilam 100 mg taken 30 min after the start of a low-fat meal.
|
Fasted Phase 2 Simufilam
n=24 Participants
All subjects after taking the Phase 2 simufilam oral tablet in a fasted state.
|
|---|---|---|---|---|
|
AUCinf
|
3980 h*ng/mL
Standard Deviation 1130
|
3900 h*ng/mL
Standard Deviation 1030
|
3930 h*ng/mL
Standard Deviation 1050
|
3960 h*ng/mL
Standard Deviation 1060
|
Adverse Events
Fasted Phase 3 Simufilam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 3 High-fat Fed Simufilam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 3 Low-fat Fed Simufilam
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fasted Phase 2 Simufilam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fasted Phase 3 Simufilam
n=24 participants at risk
All subjects following Phase 3 simufilam 100 mg tablet in a fasted state.
|
Phase 3 High-fat Fed Simufilam
n=24 participants at risk
All subjects following Phase 3 simufilam 100 mg tablet taken 30 min after the start of a high-fat meal.
|
Phase 3 Low-fat Fed Simufilam
n=24 participants at risk
All subjects following Phase 3 simufilam 100 mg tablet taken 30 min after the start of a low-fat meal.
|
Fasted Phase 2 Simufilam
n=24 participants at risk
All subjects following Phase 2 simufilam 100 mg tablet taken in a fasted state.
|
|---|---|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
|
Gastrointestinal disorders
constipation
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
Gastrointestinal disorders
abdominal distension
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
Gastrointestinal disorders
dyspepsia
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
Ear and labyrinth disorders
auditory disorder
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
General disorders
fatigue
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
|
Nervous system disorders
Parosmia
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/24 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is an employee of the CRO who conducted the study and is restricted by CDA.
- Publication restrictions are in place
Restriction type: OTHER