This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IRL757 capsules
CTC Clinical Trial Consultants AB
Uppsala, Sweden
Determination of Maximum Plasma Concentration [Cmax] of IRL757
Cmax after single dosing
Time frame: 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
Time frame: 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
Time frame: PK followed until 48 hours
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
Determination of the renal clearance (CLr) of IRL757 based on urine and plasma sampling over 48 h
Time frame: PK followed until 48 hours
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)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Until 5-10 days after IMP administration