Trial Outcomes & Findings for Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers (NCT NCT06699628)
NCT ID: NCT06699628
Last Updated: 2026-02-05
Results Overview
Cmax after single dosing
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
PK followed until 48 hours
Results posted on
2026-02-05
Participant Flow
Participant milestones
| Measure |
IRL757 Dose Level 1
IRL757 low dose, single dose
|
IRL757 Dose Level 2
IRL757 high dose, single dose
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
Baseline characteristics by cohort
| Measure |
IRL757 Dose Level 1
n=6 Participants
IRL757 low dose, single dose
|
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 4.6 • n=41 Participants
|
71.2 years
STANDARD_DEVIATION 5.3 • n=1581 Participants
|
71.5 years
STANDARD_DEVIATION 4.7 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Weight
|
77.42 kg
STANDARD_DEVIATION 13.6 • n=41 Participants
|
68.2 kg
STANDARD_DEVIATION 10.95 • n=1581 Participants
|
72.81 kg
STANDARD_DEVIATION 12.72 • n=4626 Participants
|
PRIMARY outcome
Timeframe: PK followed until 48 hoursCmax after single dosing
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Determination of Maximum Plasma Concentration [Cmax] of IRL757
|
11.42 μmol/L
Geometric Coefficient of Variation 31
|
2.88 μmol/L
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: PK followed until 48 hoursAUC 0 - inf for IRL757 and main metabolites M1 and M5 determined from PK sampling 0-48h post dosing
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Determination of the AUC of IRL757 and Its Main Metabolites
IRL757
|
101.3 h*μmol/L
Geometric Coefficient of Variation 48
|
17.36 h*μmol/L
Geometric Coefficient of Variation 47
|
|
Determination of the AUC of IRL757 and Its Main Metabolites
M1
|
2.94 h*μmol/L
Geometric Coefficient of Variation 67
|
1.08 h*μmol/L
Geometric Coefficient of Variation 12
|
|
Determination of the AUC of IRL757 and Its Main Metabolites
M5
|
10.03 h*μmol/L
Geometric Coefficient of Variation 29
|
2.27 h*μmol/L
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: PK followed until 48 hoursDetermination of the time for maximum concentration \[Tmax\] of IRL757 and its main metabolites M1 and M5
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
IRL757
|
0.75 h
Interval 0.667 to 3.0
|
0.6667 h
Interval 0.333 to 1.0
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
M1
|
2.0 h
Interval 2.0 to 4.1
|
0.84 h
Interval 0.67 to 2.0
|
|
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
M5
|
6 h
Interval 6.0 to 6.0
|
6.025 h
Interval 5.97 to 6.03
|
PRIMARY outcome
Timeframe: PK followed until 48 hoursOutcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
IRL757 t1/2
|
7.44 h
Geometric Coefficient of Variation 26
|
5.62 h
Geometric Coefficient of Variation 19
|
|
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
M1 t1/2
|
6.8 h
Geometric Coefficient of Variation 31
|
4.7 h
Geometric Coefficient of Variation 7.7
|
|
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
M5 IRL757
|
9.95 h
Geometric Coefficient of Variation 24.3
|
7.7 h
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: PK followed until 48 hoursDetermination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Determination of the Renal Clearance (CLr) of IRL757
|
0.1413 L/h
Standard Deviation 0.09284
|
0.1166 L/h
Standard Deviation .08364
|
SECONDARY outcome
Timeframe: From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)Population: 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 |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Total AEs
|
3 AE
|
1 AE
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Treatment related AEs
|
2 AE
|
0 AE
|
|
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
Severity of AEs: MILD
|
3 AE
|
1 AE
|
SECONDARY outcome
Timeframe: Until 5-10 days after IMP administrationClinically significant abnormal findings will be summarized and categorized by dose group. The physical examination will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Description of Physical Examination Findings
Abnormal Clinically Significant findings
|
0 Clinically significant abnormalities
|
0 Clinically significant abnormalities
|
SECONDARY outcome
Timeframe: Until 5-10 days after IMP administrationFollowing parameters will be measured/calculated: heart rate, PR, QRS, QT and QTc intervals. The measures will be described as "normal", "abnormal, not clinically significant", or "abnormal, clinically significant". These will be summarized and categorized by dose group.
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Description of Electrocardiogram Findings
Abnormal, not clinically significant
|
1 Participants
|
1 Participants
|
|
Description of Electrocardiogram Findings
Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until 5-10 days after IMP administrationThe following parameters will be measured as vital signs: systolic and diastolic blood pressure, heart rate and respiratory rate. Clinically significant findings will be summarized by dose group.
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Description of Vital Signs Findings
|
0 Clinically significant changes
|
0 Clinically significant changes
|
SECONDARY outcome
Timeframe: Until 5-10 days after IMP administrationCommon laboratory parameters will be assessed: clinical biochemistry panel (including for example, ALAT, ASAT, ALP, CRP, CK, Calcium, Potassium, Sodium,...), hematology panel (including white blood cell differential count), coagulation parameters (INR, APTT). Safety laboratory data will be summarized by dose group. Safety laboratory interpretations (abnormal, significant) will be summarized by dose groups, using frequency tables.
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Description of Safety Laboratory Measurements
|
0 Clinically significant abnormalities
|
0 Clinically significant abnormalities
|
SECONDARY outcome
Timeframe: Until 5-10 days after IMP administrationA physician rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Any abnormal finding will be listed.
Outcome measures
| Measure |
IRL757 Dose Level 2
n=6 Participants
IRL757 high dose, single dose
|
IRL757 Dose Level 1
n=6 Participants
IRL757, single dose
|
|---|---|---|
|
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
|
0 Abnormal findings
|
0 Abnormal findings
|
Adverse Events
IRL757 Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IRL757 Dose Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IRL757 Dose Level 1
n=6 participants at risk
IRL757 lower dose, single dose
|
IRL757 Dose Level 2
n=6 participants at risk
IRL757 higher dose, single dose
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
|
33.3%
2/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
|
16.7%
1/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
|
0.00%
0/6 • From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP 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