Trial Outcomes & Findings for First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers (NCT NCT06493045)
NCT ID: NCT06493045
Last Updated: 2026-05-15
Results Overview
Total number of AEs, and total number of AEs by severity and relationship to study treatment are presented. Refer to the Adverse Events section for more information
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Until 5-10 days after IMP administration
Results posted on
2026-05-15
Participant Flow
Participant milestones
| Measure |
SAD Cohort 1
SAD first dose. Lowest dose administered in this ascending dose trial.
|
SAD Cohort 2
SAD second dose. The second lowest dose in this ascending dose trial.
|
SAD Cohort 3
SAD third dose. The second highest dose in this ascending dose trial.
|
SAD Cohort 4
SAD fourth dose. The highest dose in this ascending dose trial.
|
SAD Cohort 5
SAD third dose repeated. I.e. the second highest dose.
|
SAD Placebo Cohort
Placebo dose.
|
SAD Food Interaction Sub-study
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
MAD first dose. Lowest dose in this ascending dose trial.
|
MAD Cohort 2
MAD second dose. Second highest dose in this ascending dose trial.
|
MAD Cohort 3
MAD third dose. Highest dose in MAD part.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Placebo Cohort
n=10 Participants
Placebo dose.
|
SAD Food Interaction Sub-study
n=6 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.0 Years
STANDARD_DEVIATION 12.5 • n=11 Participants
|
34.2 Years
STANDARD_DEVIATION 6.0 • n=9 Participants
|
28.2 Years
STANDARD_DEVIATION 7.0 • n=20 Participants
|
40.5 Years
STANDARD_DEVIATION 13.4 • n=186 Participants
|
36.2 Years
STANDARD_DEVIATION 8.9 • n=12 Participants
|
33.3 Years
STANDARD_DEVIATION 8.6 • n=12 Participants
|
38.8 Years
STANDARD_DEVIATION 12.3 • n=122 Participants
|
34.6 Years
STANDARD_DEVIATION 7.7 • n=2 Participants
|
38.1 Years
STANDARD_DEVIATION 9.9 • n=3 Participants
|
37.1 Years
STANDARD_DEVIATION 12.5 • n=3 Participants
|
32.2 Years
STANDARD_DEVIATION 11.1 • n=3 Participants
|
35.2 Years
STANDARD_DEVIATION 10.2 • n=26 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=186 Participants
|
2 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
3 Participants
n=122 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
36 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=186 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=122 Participants
|
7 Participants
n=2 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
46 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=186 Participants
|
6 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
5 Participants
n=122 Participants
|
8 Participants
n=2 Participants
|
9 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
79 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=20 Participants
|
6 Participants
n=186 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
5 Participants
n=122 Participants
|
8 Participants
n=2 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
75 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationPopulation: Total number of AEs are presented
Total number of AEs, and total number of AEs by severity and relationship to study treatment are presented. Refer to the Adverse Events section for more information
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Relationship to study treatment - Not Related
|
0 Adverse events
|
2 Adverse events
|
3 Adverse events
|
7 Adverse events
|
11 Adverse events
|
3 Adverse events
|
1 Adverse events
|
2 Adverse events
|
3 Adverse events
|
4 Adverse events
|
5 Adverse events
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Relationship to study treatment - Possible
|
0 Adverse events
|
6 Adverse events
|
6 Adverse events
|
9 Adverse events
|
7 Adverse events
|
4 Adverse events
|
0 Adverse events
|
1 Adverse events
|
1 Adverse events
|
5 Adverse events
|
14 Adverse events
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Relationship to study treatment - Probable
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Severity - Mild
|
0 Adverse events
|
9 Adverse events
|
9 Adverse events
|
15 Adverse events
|
18 Adverse events
|
7 Adverse events
|
1 Adverse events
|
3 Adverse events
|
4 Adverse events
|
9 Adverse events
|
19 Adverse events
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Severity - Moderate
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Any AE
|
0 Adverse events
|
9 Adverse events
|
9 Adverse events
|
16 Adverse events
|
18 Adverse events
|
7 Adverse events
|
1 Adverse events
|
3 Adverse events
|
4 Adverse events
|
9 Adverse events
|
19 Adverse events
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationNumber of participants with clinically significant abnormal findings on physical examination
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of Physical Examination Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationNumber of participants with clinically significant abnormal electrocardiogram findings
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of Electrocardiogram Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationNumber of participants with clinically significant abnormal vital signs findings
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of Vital Signs Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationNumber of participants with clinically significant abnormal safety laboratory measurements
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of Safety Laboratory Measurements
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until 5-10 days after IMP administrationNumber of Participants With Suicidal Thoughts or Attempts
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=10 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=6 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
MAD Placebo Cohort
n=9 Participants
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until 48 hours post-dosePopulation: Steady state PK parameters are not applicable for the single dose (SAD) cohorts. Fed condition parameters are only applicable for the food interaction sub-study.
Geometric mean and geometric coefficient of variation (CV%) for maximum plasma concentration. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=6 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
MAD third dose.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
IRL757
|
11.26 umol/L
Geometric Coefficient of Variation 21.9
|
9.709 umol/L
Geometric Coefficient of Variation 9.87
|
2.228 umol/L
Geometric Coefficient of Variation 18.7
|
6.002 umol/L
Geometric Coefficient of Variation 16.5
|
12.79 umol/L
Geometric Coefficient of Variation 15.7
|
2.837 umol/L
Geometric Coefficient of Variation 34.5
|
5.884 umol/L
Geometric Coefficient of Variation 13.2
|
9.543 umol/L
Geometric Coefficient of Variation 10.7
|
24.18 umol/L
Geometric Coefficient of Variation 17.7
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M1
|
0.1237 umol/L
Geometric Coefficient of Variation 78.5
|
0.08305 umol/L
Geometric Coefficient of Variation 75.4
|
0.03797 umol/L
Geometric Coefficient of Variation 119
|
0.03989 umol/L
Geometric Coefficient of Variation 72.4
|
0.2334 umol/L
Geometric Coefficient of Variation 126
|
0.04644 umol/L
Geometric Coefficient of Variation 138
|
0.09647 umol/L
Geometric Coefficient of Variation 132
|
0.1563 umol/L
Geometric Coefficient of Variation 80.3
|
0.3007 umol/L
Geometric Coefficient of Variation 65.5
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M5
|
0.3811 umol/L
Geometric Coefficient of Variation 32.8
|
0.3352 umol/L
Geometric Coefficient of Variation 31.1
|
0.1079 umol/L
Geometric Coefficient of Variation 19.5
|
0.2045 umol/L
Geometric Coefficient of Variation 16.8
|
0.3451 umol/L
Geometric Coefficient of Variation 31.2
|
0.09834 umol/L
Geometric Coefficient of Variation 12.7
|
0.1841 umol/L
Geometric Coefficient of Variation 21.8
|
0.3745 umol/L
Geometric Coefficient of Variation 28.8
|
0.6578 umol/L
Geometric Coefficient of Variation 20.9
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M7
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
IRL757 Steady state
|
—
|
—
|
5.059 umol/L
Geometric Coefficient of Variation 32.6
|
12.24 umol/L
Geometric Coefficient of Variation 27.7
|
23.27 umol/L
Geometric Coefficient of Variation 35.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M1 Steady state
|
—
|
—
|
0.06238 umol/L
Geometric Coefficient of Variation 103
|
0.1093 umol/L
Geometric Coefficient of Variation 54.9
|
0.4950 umol/L
Geometric Coefficient of Variation 76.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M5 Steady state
|
—
|
—
|
0.1079 umol/L
Geometric Coefficient of Variation 17.4
|
0.1504 umol/L
Geometric Coefficient of Variation 21.8
|
0.2328 umol/L
Geometric Coefficient of Variation 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M7 Steady state
|
—
|
—
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
0.05658 umol/L
Geometric Coefficient of Variation 27.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
IRL757 Fed
|
—
|
7.679 umol/L
Geometric Coefficient of Variation 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M1 Fed
|
—
|
0.06769 umol/L
Geometric Coefficient of Variation 85.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M5 Fed
|
—
|
0.1712 umol/L
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757 and Its 3 Main Metabolites
M7 Fed
|
—
|
NA umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until 48 hours post-dosePopulation: Steady state PK parameters are not applicable for the single dose (SAD) cohorts. Fed condition parameters are only applicable for the food interaction sub-study.
Geometric mean and geometric coefficient of variation (CV%) for area under the plasma concentration-time curve (AUC0-inf for SAD and AUC0-tau for MAD). Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=6 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
MAD third dose.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M7
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
IRL757 Steady state
|
—
|
—
|
44.66 h*umol/L
Geometric Coefficient of Variation 41.2
|
105.1 h*umol/L
Geometric Coefficient of Variation 36.6
|
184.0 h*umol/L
Geometric Coefficient of Variation 51.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
IRL757
|
134.0 h*umol/L
Geometric Coefficient of Variation 48.2
|
118.8 h*umol/L
Geometric Coefficient of Variation 18.3
|
15.85 h*umol/L
Geometric Coefficient of Variation 18.8
|
37.11 h*umol/L
Geometric Coefficient of Variation 20.2
|
77.13 h*umol/L
Geometric Coefficient of Variation 22.2
|
24.73 h*umol/L
Geometric Coefficient of Variation 58.6
|
56.21 h*umol/L
Geometric Coefficient of Variation 40.1
|
78.06 h*umol/L
Geometric Coefficient of Variation 37.1
|
403.4 h*umol/L
Geometric Coefficient of Variation 41.2
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M1
|
1.910 h*umol/L
Geometric Coefficient of Variation 34.6
|
1.291 h*umol/L
Geometric Coefficient of Variation 67.0
|
0.5716 h*umol/L
Geometric Coefficient of Variation 79.2
|
0.3715 h*umol/L
Geometric Coefficient of Variation 67.0
|
1.946 h*umol/L
Geometric Coefficient of Variation 111
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
1.490 h*umol/L
Geometric Coefficient of Variation 52.1
|
1.642 h*umol/L
Geometric Coefficient of Variation 65.5
|
5.181 h*umol/L
Geometric Coefficient of Variation 67.6
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M5
|
7.724 h*umol/L
Geometric Coefficient of Variation 19.3
|
7.379 h*umol/L
Geometric Coefficient of Variation 25.9
|
0.8983 h*umol/L
Geometric Coefficient of Variation 20.3
|
1.734 h*umol/L
Geometric Coefficient of Variation 16.2
|
2.879 h*umol/L
Geometric Coefficient of Variation 32.2
|
1.889 h*umol/L
Geometric Coefficient of Variation 36.5
|
3.880 h*umol/L
Geometric Coefficient of Variation 20.3
|
5.942 h*umol/L
Geometric Coefficient of Variation 33.0
|
14.01 h*umol/L
Geometric Coefficient of Variation 24.1
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M1 Steady state
|
—
|
—
|
0.5687 h*umol/L
Geometric Coefficient of Variation 105
|
1.023 h*umol/L
Geometric Coefficient of Variation 53.1
|
4.260 h*umol/L
Geometric Coefficient of Variation 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M5 Steady state
|
—
|
—
|
1.209 h*umol/L
Geometric Coefficient of Variation 19.7
|
1.674 h*umol/L
Geometric Coefficient of Variation 22.3
|
2.479 h*umol/L
Geometric Coefficient of Variation 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M7 Steady state
|
—
|
—
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
0.5515 h*umol/L
Geometric Coefficient of Variation 25.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
IRL757 Fed
|
—
|
144.7 h*umol/L
Geometric Coefficient of Variation 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M1 Fed
|
—
|
1.652 h*umol/L
Geometric Coefficient of Variation 76.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M5 Fed
|
—
|
4.792 h*umol/L
Geometric Coefficient of Variation 32.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the AUC of IRL757 and Its 3 Main Metabolites After Single and Multiple Dose
M7 Fed
|
—
|
NA h*umol/L
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until 48 hours post-dosePopulation: Steady state PK parameters are not applicable for the single dose (SAD) cohorts. Fed condition parameters are only applicable for the food interaction sub-study.
Median time to maximum plasma concentration with full range (minimum, maximum). Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=6 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
MAD third dose.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M1
|
3.500 hours
Interval 1.98 to 4.05
|
3.992 hours
Interval 2.0 to 4.02
|
3.000 hours
Interval 2.98 to 4.0
|
3.000 hours
Interval 1.05 to 4.0
|
3.000 hours
Interval 0.667 to 3.98
|
3.500 hours
Interval 2.0 to 8.0
|
4.000 hours
Interval 2.0 to 6.0
|
3.000 hours
Interval 2.0 to 4.0
|
4.000 hours
Interval 3.0 to 4.02
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M5
|
6.000 hours
Interval 6.0 to 8.0
|
6.000 hours
Interval 5.92 to 8.0
|
6.000 hours
Interval 5.93 to 10.1
|
6.000 hours
Interval 6.0 to 7.98
|
6.017 hours
Interval 6.0 to 10.0
|
6.000 hours
Interval 6.0 to 10.0
|
6.000 hours
Interval 5.98 to 8.0
|
8.000 hours
Interval 4.0 to 8.03
|
6.000 hours
Interval 6.0 to 6.1
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
IRL757
|
0.8250 hours
Interval 0.667 to 6.0
|
1.033 hours
Interval 1.0 to 2.0
|
1.000 hours
Interval 0.667 to 8.0
|
0.6833 hours
Interval 0.333 to 1.05
|
0.6833 hours
Interval 0.667 to 2.02
|
1.517 hours
Interval 0.667 to 2.08
|
1.508 hours
Interval 0.667 to 3.0
|
1.000 hours
Interval 0.667 to 1.02
|
2.000 hours
Interval 1.03 to 6.0
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M5 Steady state
|
—
|
—
|
6.000 hours
Interval 2.0 to 6.07
|
5.983 hours
Interval 1.0 to 6.12
|
4.000 hours
Interval 0.667 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M7 Fed
|
—
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M7
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
IRL757 Steady state
|
—
|
—
|
1.017 hours
Interval 0.667 to 3.02
|
0.9833 hours
Interval 0.667 to 2.02
|
1.000 hours
Interval 0.667 to 6.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M1 Steady state
|
—
|
—
|
3.000 hours
Interval 1.0 to 4.02
|
2.050 hours
Interval 1.0 to 4.02
|
3.000 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M7 Steady state
|
—
|
—
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
8.050 hours
Interval 6.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
IRL757 Fed
|
—
|
5.983 hours
Interval 3.98 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M1 Fed
|
—
|
7.033 hours
Interval 5.98 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its 3 Main Metabolites
M5 Fed
|
—
|
11.00 hours
Interval 8.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until 48 hours post-dosePopulation: Steady state PK parameters are not applicable for the single dose (SAD) cohorts. Fed condition parameters are only applicable for the food interaction sub-study.
Geometric mean and geometric coefficient of variation (CV%) for terminal elimination half-life. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=6 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
n=9 Participants
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
MAD third dose.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M5
|
11.47 hours
Geometric Coefficient of Variation 29.0
|
13.05 hours
Geometric Coefficient of Variation 15.2
|
15.15 hours
Geometric Coefficient of Variation 78.6
|
12.35 hours
Geometric Coefficient of Variation 51.1
|
10.87 hours
Geometric Coefficient of Variation 32.0
|
10.30 hours
Geometric Coefficient of Variation 31.9
|
11.69 hours
Geometric Coefficient of Variation 28.3
|
8.791 hours
Geometric Coefficient of Variation 21.6
|
13.08 hours
Geometric Coefficient of Variation 14.4
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M1
|
9.538 hours
Geometric Coefficient of Variation 45.2
|
9.514 hours
Geometric Coefficient of Variation 22.3
|
7.645 hours
Geometric Coefficient of Variation 17.6
|
7.111 hours
Geometric Coefficient of Variation 36.1
|
6.185 hours
Geometric Coefficient of Variation 66.9
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
5.202 hours
Geometric Coefficient of Variation 27.0
|
5.495 hours
Geometric Coefficient of Variation 47.1
|
10.28 hours
Geometric Coefficient of Variation 32.3
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M1 Fed
|
—
|
11.84 hours
Geometric Coefficient of Variation 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
IRL757
|
8.969 hours
Geometric Coefficient of Variation 48.1
|
9.659 hours
Geometric Coefficient of Variation 8.92
|
6.174 hours
Geometric Coefficient of Variation 27.5
|
6.193 hours
Geometric Coefficient of Variation 23.6
|
5.925 hours
Geometric Coefficient of Variation 33.0
|
6.681 hours
Geometric Coefficient of Variation 40.0
|
6.813 hours
Geometric Coefficient of Variation 36.7
|
5.874 hours
Geometric Coefficient of Variation 33.5
|
11.35 hours
Geometric Coefficient of Variation 22.3
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M7
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
IRL757 Steady state
|
—
|
—
|
12.05 hours
Geometric Coefficient of Variation 19.8
|
11.65 hours
Geometric Coefficient of Variation 29.9
|
10.50 hours
Geometric Coefficient of Variation 38.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M1 Steady state
|
—
|
—
|
10.59 hours
Geometric Coefficient of Variation 39.8
|
13.03 hours
Geometric Coefficient of Variation 61.2
|
11.07 hours
Geometric Coefficient of Variation 43.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M5 Steady state
|
—
|
—
|
23.95 hours
Geometric Coefficient of Variation 34.2
|
23.48 hours
Geometric Coefficient of Variation 30.3
|
20.36 hours
Geometric Coefficient of Variation 44.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M7 Steady state
|
—
|
—
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
82.96 hours
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
IRL757 Fed
|
—
|
10.47 hours
Geometric Coefficient of Variation 9.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M5 Fed
|
—
|
15.20 hours
Geometric Coefficient of Variation 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Half-life [t1/2] of IRL757 and Its 3 Main Metabolites
M7 Fed
|
—
|
NA hours
Geometric Coefficient of Variation NA
Not calculated - number of evaluable observations (\>= LoQ) less than 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Until 48 hours post-dosePopulation: Steady state PK parameters are not applicable for the single dose (SAD) cohorts. For the multiple dose (MAD) cohorts, the renal clearance calculation is only applicable for the steady state condition, since renal clearance calculations after a single dose must be based on AUC 0-infinity and urine recovery 0-infinity, which cannot be assessed on day 1 in a multiple-dosing paradigm.
Geometric mean and geometric coefficient of variation (CV%) for renal clearance. Data from Pharmacokinetic analysis set. All samples from all participants were subject to analysis of IRL757 and main metabolite concentrations.
Outcome measures
| Measure |
SAD Cohort 5
n=6 Participants
SAD third dose repeated.
|
SAD Food Interaction Sub-study
n=9 Participants
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 Participants
MAD first dose.
|
MAD Cohort 2
n=9 Participants
MAD second dose.
|
MAD Cohort 3
MAD third dose.
|
SAD Cohort 1
n=6 Participants
SAD first dose.
|
SAD Cohort 2
n=6 Participants
SAD second dose.
|
SAD Cohort 3
n=6 Participants
SAD third dose.
|
SAD Cohort 4
n=6 Participants
SAD fourth dose.
|
MAD Cohort 3
MAD third dose.
|
MAD Placebo Cohort
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determination of the Renal Clearance (CLr) of IRL757
IRL757 Day 1
|
0.08338 L/h
Geometric Coefficient of Variation 33.1
|
—
|
—
|
—
|
—
|
0.09142 L/h
Geometric Coefficient of Variation 83.8
|
0.06989 L/h
Geometric Coefficient of Variation 38.6
|
0.1260 L/h
Geometric Coefficient of Variation 26.7
|
0.09058 L/h
Geometric Coefficient of Variation 64.5
|
—
|
—
|
|
Determination of the Renal Clearance (CLr) of IRL757
IRL757 Steady state
|
—
|
0.1141 L/h
Geometric Coefficient of Variation 46.4
|
0.08829 L/h
Geometric Coefficient of Variation 47.0
|
0.08091 L/h
Geometric Coefficient of Variation 42.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SAD Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD Placebo Cohort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SAD Food Interaction Sub-study
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MAD Cohort 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MAD Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD Placebo Cohort
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD Cohort 1
n=6 participants at risk
SAD first dose.
|
SAD Cohort 2
n=6 participants at risk
SAD second dose.
|
SAD Cohort 3
n=6 participants at risk
SAD third dose.
|
SAD Cohort 4
n=6 participants at risk
SAD fourth dose.
|
SAD Cohort 5
n=6 participants at risk
SAD third dose repeated.
|
SAD Placebo Cohort
n=10 participants at risk
Placebo dose.
|
SAD Food Interaction Sub-study
n=6 participants at risk
6 subjects received IMP (SAD third dose) under fasted and then fed condition.
|
MAD Cohort 1
n=9 participants at risk
MAD first dose.
|
MAD Cohort 2
n=9 participants at risk
MAD second dose.
|
MAD Cohort 3
n=9 participants at risk
MAD third dose.
|
MAD Placebo Cohort
n=9 participants at risk
MAD placebo dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
General disorders
Chills
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
10.0%
1/10 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
20.0%
2/10 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
22.2%
2/9 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
22.2%
2/9 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
33.3%
3/9 • Number of events 3 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
20.0%
2/10 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
33.3%
2/6 • Number of events 4 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
30.0%
3/10 • Number of events 3 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
33.3%
3/9 • Number of events 6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
44.4%
4/9 • Number of events 8 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
22.2%
2/9 • Number of events 3 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
44.4%
4/9 • Number of events 10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
10.0%
1/10 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
16.7%
1/6 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
11.1%
1/9 • Number of events 1 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/10 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/6 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
22.2%
2/9 • Number of events 2 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
0.00%
0/9 • From first IMP administration until follow-up visit 5-10 days after last IMP administration
|
Additional Information
Joakim Tedroff
Integrative Research Laboratories Sweden AB
Phone: +46 31 757 38 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER