Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy SubjectsPhase 1NCT06699628
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
A Phase 1 study testing IRL757 in people with Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects and Apathy, run by Integrative Research Laboratories AB at 1 site in Sweden.
Trial summary
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
- What is being tested?
- IRL757
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 23 Sep 2024to 11 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or postmenopausal 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, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Willing to use highly effective methods of contraception
Who cannot join
- History of any clinically significant 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.
- GFR 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.
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- Any planned major surgery within the duration of the trial.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (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 QTcF (above 450 ms for male subjects or 470 ms for female subjects), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open-label, Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
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.
- Conditions
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
- Being tested
- IRL757
- Medical subject headings
- Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRL757Drug
IRL757 capsules
| Study group | Role | What they receive |
|---|---|---|
| IRL757 Dose Level 1 | Experimental | IRL757 lower dose, single dose Receives: Drug: IRL757 |
| IRL757 Dose Level 2 | Experimental | IRL757 higher dose, single dose Receives: Drug: IRL757 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Plasma Concentration [Cmax] of IRL757
Cmax after single dosing
Measured: PK followed until 48 hours
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
Measured: PK followed until 48 hours
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
Measured: PK followed until 48 hours
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
Measured: PK followed until 48 hours
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
Measured: PK followed until 48 hours
Secondary outcomes (6)
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
Measured: From enrollment (within 4 weeks before Investigational Medicinal Product (IMP) administration, until end of follow-up (5 to 10 days after lMP administration)
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.
Measured: Until 5-10 days after IMP administration
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.
Measured: Until 5-10 days after IMP administration
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.
Measured: Until 5-10 days after IMP administration
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.
Measured: Until 5-10 days after IMP administration
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.
Measured: Until 5-10 days after IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start23 Sep 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Ascending doses
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Research Laboratories AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699628
- Sponsor's protocol ID
- IRL757C002
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label, Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT06699628
- Acronym / sponsor ID
- IRL757C002
- Conditions
- Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Posted 5 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ascending doses
| Arm | Type | Receives |
|---|---|---|
| IRL757 Dose Level 1 | Experimental | Drug: IRL757IRL757 lower dose, single dose |
| IRL757 Dose Level 2 | Experimental | Drug: IRL757IRL757 higher dose, single dose |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the trial.
- Healthy male or postmenopausal 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, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Willing to use highly effective methods of contraception
Key exclusion criteria (23 listed)
- History of any clinically significant 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.
- GFR 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRL757IRL757 capsules | Drug | IRL757 Dose Level 1, IRL757 Dose Level 2 |
Primary outcome
Determination of Maximum Plasma Concentration [Cmax] of IRL757
Time frame: PK followed until 48 hours
Cmax after single dosing
Determination of the AUC of IRL757 and Its Main Metabolites
Time frame: PK followed until 48 hours
AUC 0 - inf for IRL757 and main metabolites M1 and M5 determined from PK sampling 0-48h post dosing
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
Time frame: PK followed until 48 hours
Determination of the time for maximum concentration [Tmax] of IRL757 and its main metabolites M1 and M5
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
Time frame: PK followed until 48 hours
Determination of the Renal Clearance (CLr) of IRL757
Time frame: PK followed until 48 hours
Determination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h
6 secondary outcomes
Evaluation of Frequency, Seriousness and Intensity of Adverse Events
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)
Description of Physical Examination Findings
Time frame: Until 5-10 days after IMP administration
Description of Electrocardiogram Findings
Time frame: Until 5-10 days after IMP administration
Description of Vital Signs Findings
Time frame: Until 5-10 days after IMP administration
Description of Safety Laboratory Measurements
Time frame: Until 5-10 days after IMP administration
Description of C-SSRS (Columbia Suicide Severity Rating Scale) Findings
Time frame: Until 5-10 days after IMP administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IRL757 in people with Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects and Apathy, run by Integrative Research Laboratories AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Plasma Concentration [Cmax] of IRL757 (time frame: PK followed until 48 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.