Trial Outcomes & Findings for The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (NCT NCT05451017)
NCT ID: NCT05451017
Last Updated: 2026-01-22
Results Overview
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
TERMINATED
PHASE1
22 participants
up to 312 hours after dosing
2026-01-22
Participant Flow
Participant milestones
| Measure |
AEF0117 1.0 mg in Fasted Condition
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
AEF0117 1.0 mg in Fed Condition
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
AEF0117 1.0 mg in Fed Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=270 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Weight
|
85.45 kg
STANDARD_DEVIATION 11.46 • n=270 Participants
|
81.25 kg
STANDARD_DEVIATION 13.65 • n=4 Participants
|
83.35 kg
STANDARD_DEVIATION 12.48 • n=9 Participants
|
|
Body Mass Index
|
27.195 kg/m2
STANDARD_DEVIATION 3.161 • n=270 Participants
|
26.307 kg/m2
STANDARD_DEVIATION 3.145 • n=4 Participants
|
26.751 kg/m2
STANDARD_DEVIATION 3.110 • n=9 Participants
|
PRIMARY outcome
Timeframe: up to 312 hours after dosingPopulation: 1 subject in the Fed group was excluded from the pharcokinetic population due to missing data with 24 hours
Plasma concentration maximum(Cmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Cmax of AEF0117
|
6.87 pg/mL
Geometric Coefficient of Variation 38.0
|
3.76 pg/mL
Geometric Coefficient of Variation 28.6
|
PRIMARY outcome
Timeframe: up to 312 hours after dosingPopulation: 1 subject in the Fed group was excluded from the pharcokinetic population due to missing data with 24 hours
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Tmax of AEF0117
|
3.5165 hours
Interval 2.017 to 6.0
|
3.0000 hours
Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: up to 312 hours after dosingPopulation: 1 subject in the Fed group was excluded from the pharcokinetic population due to missing data with 24 hours
Area under the plasma concentration (AUC to Last Nonzero Conc) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
AUC (Area Under Curve) t to Last Concentration of AEF0117
|
61.50 hours*pg/mL
Geometric Coefficient of Variation 22.0
|
34.43 hours*pg/mL
Geometric Coefficient of Variation 27.8
|
PRIMARY outcome
Timeframe: up to 312 hours after dosingPopulation: 1 subject in the Fed group was excluded from the pharcokinetic population due to missing data with 24 hours
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
AUC (Area Under Curve) t to Infinity Observed of AEF0117
|
70.86 hours*pg/mL
Geometric Coefficient of Variation 23.7
|
42.14 hours*pg/mL
Geometric Coefficient of Variation 26.0
|
PRIMARY outcome
Timeframe: up to 312 hours after dosingPopulation: 1 subject in the Fed group was excluded from the pharmacokinetic population due to missing data with 24 hours
Tlag is the Time point of first quantifiable concentration after dose administration
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Bioavailibility of AEF0117 (Tlag)
|
0.5000 hours
Interval 0.0 to 1.0
|
0.0000 hours
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: up to 312 hours after dosingLowest Peak Plasma (Cmin) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure
|
373.9108 pg/mL
Standard Deviation 149.2681
|
154.1652 pg/mL
Standard Deviation 62.7416
|
SECONDARY outcome
Timeframe: up to 312 hours after dosingTerminal elimination half-life (t1/2) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=10 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of AEF0117
|
170.5580 hours
Interval 32.523 to 212.973
|
212.3460 hours
Interval 181.76 to 242.721
|
SECONDARY outcome
Timeframe: up to 312 hours after AEF0217 dosingNumber of participant reporting at least one Adverse Event
Outcome measures
| Measure |
AEF0117 1.0 mg Once Daily (QD) in Fed Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 Participants
11 participants receive 1 dose of AEF0117 1 mg in fasted condition
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Event
|
3 Participants
|
6 Participants
|
Adverse Events
AEF0117 1.0 mg in Fed Condition
AEF0117 1.0 mg in Fasted Condition
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AEF0117 1.0 mg in Fed Condition
n=11 participants at risk
11 participants receive 1 dose of AEF0117 1 mg fed condition
|
AEF0117 1.0 mg in Fasted Condition
n=11 participants at risk
11 participants receive 1 dose of AEF0117 1 mg fasted condition
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/11 • from D1 (IP administration) until D14
|
27.3%
3/11 • Number of events 3 • from D1 (IP administration) until D14
|
|
Nervous system disorders
Brain Fog
|
0.00%
0/11 • from D1 (IP administration) until D14
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
|
General disorders
Malaise
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
0.00%
0/11 • from D1 (IP administration) until D14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • from D1 (IP administration) until D14
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
|
Nervous system disorders
coordination abnormal
|
0.00%
0/11 • from D1 (IP administration) until D14
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
0.00%
0/11 • from D1 (IP administration) until D14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • from D1 (IP administration) until D14
|
0.00%
0/11 • from D1 (IP administration) until D14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60