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

NCT06699628 | Completed Phase 1 Results

• 1 other identifier: IRL757C002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Determination of Maximum Plasma Concentration [Cmax] of IRL757

  Cmax after single dosing

  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

  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

  PK followed until 48 hours

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

  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

  PK followed until 48 hours

Secondary Outcomes (6)

• Evaluation of Frequency, Seriousness and Intensity of Adverse Events

  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

  Until 5-10 days after IMP administration

• Description of Electrocardiogram Findings

  Until 5-10 days after IMP administration

• Description of Vital Signs Findings

  Until 5-10 days after IMP administration

• Description of Safety Laboratory Measurements

  Until 5-10 days after IMP administration

Study Arms (2)

IRL757 Dose Level 1

EXPERIMENTAL

IRL757 lower dose, single dose

Drug: IRL757

IRL757 Dose Level 2

EXPERIMENTAL

IRL757 higher dose, single dose

Drug: IRL757

Interventions

IRL757 DRUG

IRL757 capsules

IRL757 Dose Level 1; IRL757 Dose Level 2

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Integrative Research Laboratories AB: lead

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, Sweden

Location

MeSH Terms

Conditions

Lethargy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joakim Tedroff
• Organization: Integrative Research Laboratories Sweden AB

info@irlab.se

+46 31 757 38 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ascending doses

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 21, 2024
• Study Start: September 23, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Locations

SE (1)