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CompletedNCT06699628Updated Feb 5, 2026Results posted

Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers

A Phase 1 interventional study of IRL757 in Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects and Apathy, sponsored by Integrative Research Laboratories AB. Completed at 1 site in Sweden. Open to participants aged 65 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Integrative Research Laboratories AB · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
65 Years to 89 Years
Sex
All
01

Study summary

This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.

Read the detailed description

The trial is open label single oral dose trial in elderly healthy volunteers that will assess the pharmacokinetics of two dose levels of IRL757.

Eligible and consenting participants will be included in one of two dose groups, with 6 participants in each dose group.

At the screening visit, consenting subjects will be screened for eligibility according to study specific inclusion/exclusion criteria within 4 weeks before Investigational Medicinal Product (IMP) administration.

If eligible, participants will be admitted to the phase 1 clinic for the single dose administration of the IMP. All participants will receive active treatment (IRL757).

A follow-up visit will be performed for all participants, 5-10 days after IMP administration.

Blood and urine sampling will be performed for determination of pharmacokinetic parameters. Safety assessments will also be performed throughout the study: review and collection of adverse events, physical examination, suicidality ideation, electrocardiogram recording, vital signs, safety laboratory assessments.

02

Conditions studied

  • Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects
  • Apathy
03

In context

Lead sponsor

Integrative Research Laboratories AB is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to give written for participation in the trial.
  • Healthy male or female subject at ≥ 65 and below 90 years of age.
  • Weight of at least 50 kg and no more than 110 kg at screening.
  • Clinically normal medical history, physical findings, vital signs, and laboratory values at the time of screening, as judged by the Investigator.
  • Willing to use highly effective methods of

Exclusion criteria

Exclusion Criteria:

  • History of any disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
  • less than 45 mL/min at screening.
  • History or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
  • Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
  • History of seizures, including febrile seizure in childhood.
  • Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the first administration of IMP.
  • Any planned major surgery within the duration of the trial.
  • Any positive result on screening for serum surface antigen, antibody and (HIV).

  • After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

    • Systolic blood pressure above 150 mm Hg
    • Diastolic blood pressure above 90 mm Hg
    • Heart rate less than 40 or above 90 beats per minute
  • Prolonged (above 450 ms for male subjects or 470 ms for female subjects), cardiac arrhythmias or any clinically significant abnormalities in the resting at the time of screening, as judged by the Investigator.
  • History of severe allergy/ or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL757.
  • Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two (2) weeks prior to the first administration of IMP
  • Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within three (3) months of the first administration of IMP in this trial.
  • Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three (3) times per week is allowed before screening visit.
  • History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
  • Positive screen for drugs of abuse at screening or on admission to the unit or positive screen for alcohol at screening or on admission to the unit prior to administration of the IMP.
  • Use of anabolic steroids.
  • Current excessive use of caffeine, as judged by the Investigator.
  • Plasma donation within one (1) month of screening or any blood donation/blood loss more than 450 mL during the three (3) months prior to screening.
  • Investigator considers the subject unlikely to comply with trial procedures, restrictions and requirements.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    IRL757 Dose Level 1

    IRL757 lower dose, single dose

    Drug: IRL757

  • Experimental
    IRL757 Dose Level 2

    IRL757 higher dose, single dose

    Drug: IRL757

Interventions

06

What researchers measure

Primary outcomes

  1. Determination of Maximum Plasma Concentration [Cmax] of IRL757

    Cmax after single dosing

    Time frame: PK followed until 48 hours

  2. Determination of the AUC of IRL757 and Its Main Metabolites

    AUC 0 - inf for IRL757 and main metabolites M1 and M5 determined from PK sampling 0-48h post dosing

    Time frame: PK followed until 48 hours

  3. Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites

    Determination of the time for maximum concentration \[Tmax\] of IRL757 and its main metabolites M1 and M5

    Time frame: PK followed until 48 hours

  4. Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites

    Time frame: PK followed until 48 hours

  5. Determination of the Renal Clearance (CLr) of IRL757

    Determination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h

    Time frame: PK followed until 48 hours

Secondary outcomes

  1. Evaluation of Frequency, Seriousness and Intensity of Adverse Events

    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

    Time frame: From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)

  2. Description of Physical Examination Findings

    Clinically 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.

    Time frame: Until 5-10 days after IMP administration

  3. Description of Electrocardiogram Findings

    Following 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.

    Time frame: Until 5-10 days after IMP administration

  4. Description of Vital Signs Findings

    The 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.

    Time frame: Until 5-10 days after IMP administration

  5. Description of Safety Laboratory Measurements

    Common 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.

    Time frame: Until 5-10 days after IMP administration

  6. Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings

    A 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.

    Time frame: Until 5-10 days after IMP administration

07

Results

Posted Feb 5, 2026

Participant flow

Participant flow — Overall Study
MilestoneIRL757 Dose Level 1IRL757 Dose Level 2
Started66
Completed66
Not completed00

Outcome measures

PrimaryDetermination of Maximum Plasma Concentration [Cmax] of IRL757

Cmax after single dosing

Time frame:
PK followed until 48 hours
Reported as:
Geometric mean · μmol/L
Determination of Maximum Plasma Concentration [Cmax] of IRL757
μmol/LIRL757 Dose Level 1IRL757 Dose Level 2
Determination of Maximum Plasma Concentration [Cmax] of IRL7572.88 ± 2611.42 ± 31
PrimaryDetermination of the AUC of IRL757 and Its Main Metabolites

AUC 0 - inf for IRL757 and main metabolites M1 and M5 determined from PK sampling 0-48h post dosing

Time frame:
PK followed until 48 hours
Reported as:
Geometric mean · h*μmol/L
Determination of the AUC of IRL757 and Its Main Metabolites
h*μmol/LIRL757 Dose Level 1IRL757 Dose Level 2
IRL75717.36 ± 47101.3 ± 48
M11.08 ± 122.94 ± 67
M52.27 ± 4210.03 ± 29
PrimaryDetermination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites

Determination of the time for maximum concentration \[Tmax\] of IRL757 and its main metabolites M1 and M5

Time frame:
PK followed until 48 hours
Reported as:
Median · h
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
hIRL757 Dose Level 1IRL757 Dose Level 2
IRL7570.6667 (0.333 to 1.00)0.75 (0.667 to 3.00)
M10.84 (0.67 to 2.0)2.0 (2.0 to 4.1)
M56.025 (5.97 to 6.03)6 (6 to 6)
PrimaryDetermination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
Time frame:
PK followed until 48 hours
Reported as:
Geometric mean · h
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
hIRL757 Dose Level 1IRL757 Dose Level 2
IRL757 t1/25.62 ± 197.44 ± 26
M1 t1/24.7 ± 7.76.8 ± 31
M5 IRL7577.7 ± 29.69.95 ± 24.3
PrimaryDetermination of the Renal Clearance (CLr) of IRL757

Determination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h

Time frame:
PK followed until 48 hours
Reported as:
Mean · L/h
Determination of the Renal Clearance (CLr) of IRL757
L/hIRL757 Dose Level 1IRL757 Dose Level 2
Determination of the Renal Clearance (CLr) of IRL7570.1166 ± .083640.1413 ± 0.09284
SecondaryEvaluation of Frequency, Seriousness and Intensity of Adverse Events

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

Time frame:
From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
Reported as:
Number · AE
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
AEIRL757 Dose Level 1IRL757 Dose Level 2
Total AEs13
Treatment related AEs02
Severity of AEs: MILD13
SecondaryDescription of Physical Examination Findings

Clinically 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.

Time frame:
Until 5-10 days after IMP administration
Reported as:
Number · Clinically significant abnormalities
Description of Physical Examination Findings
Clinically significant abnormalitiesIRL757 Dose Level 1IRL757 Dose Level 2
Abnormal Clinically Significant findings00
SecondaryDescription of Electrocardiogram Findings

Following 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.

Time frame:
Until 5-10 days after IMP administration
Reported as:
Count of participants · Participants
Description of Electrocardiogram Findings
ParticipantsIRL757 Dose Level 1IRL757 Dose Level 2
Abnormal, not clinically significant11
Abnormal, clinically significant00
SecondaryDescription of Vital Signs Findings

The 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.

Time frame:
Until 5-10 days after IMP administration
Reported as:
Number · Clinically significant changes
Description of Vital Signs Findings
Clinically significant changesIRL757 Dose Level 1IRL757 Dose Level 2
Description of Vital Signs Findings00
SecondaryDescription of Safety Laboratory Measurements

Common 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.

Time frame:
Until 5-10 days after IMP administration
Reported as:
Number · Clinically significant abnormalities
Description of Safety Laboratory Measurements
Clinically significant abnormalitiesIRL757 Dose Level 1IRL757 Dose Level 2
Description of Safety Laboratory Measurements00
SecondaryDescription of C-SSRS (Columbia Suicide Severity Rating Scale) Findings

A 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.

Time frame:
Until 5-10 days after IMP administration
Reported as:
Number · Abnormal findings
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
Abnormal findingsIRL757 Dose Level 1IRL757 Dose Level 2
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings00

Adverse events

Collected over From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IRL757 Dose Level 10/6 (0%)0/6 (0%)1/6 (16.7%)
IRL757 Dose Level 20/6 (0%)0/6 (0%)2/6 (33.3%)
Most frequent other events
Most frequent other events
EventIRL757 Dose Level 1IRL757 Dose Level 2
HeadacheNervous system disorders0/62/6
NasopharyngitisInfections and infestations0/61/6
ArthralgiaMusculoskeletal and connective tissue disorders1/60/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)IRL757 Dose Level 1IRL757 Dose Level 2Total
Mean71.8 ± 4.671.2 ± 5.371.5 ± 4.7
Sex: Female, Male
Sex: Female, Male(Participants)IRL757 Dose Level 1IRL757 Dose Level 2Total
Female358
Male314
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IRL757 Dose Level 1IRL757 Dose Level 2Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White6612
More than one race000
Unknown or Not Reported000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)IRL757 Dose Level 1IRL757 Dose Level 2Total
Hispanic or Latino000
Not Hispanic or Latino6612
Unknown or Not Reported000
Weight
Weight(kg)IRL757 Dose Level 1IRL757 Dose Level 2Total
Mean77.42 ± 13.668.2 ± 10.9572.81 ± 12.72
08

Study locations

1 site
  • CTC Clinical Trial Consultants AB
    Uppsala, Sweden
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2024 to primary completion in Nov 2024, 1 month.

Results were first posted in Feb 2026, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2024
First posted
Nov 21, 2024
StartActual
Sep 23, 2024
Primary completionActual
Nov 11, 2024
CompletionActual
Nov 11, 2024
Results first posted
Feb 5, 2026
Last update
Feb 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06699628
Lead sponsor
Integrative Research Laboratories AB
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Sep 23, 2024
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024
Results posted
Feb 5, 2026
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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