Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy… (NCT06699628) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
Sweden12 participantsStarted 2024-09-23
Plain-language summary
This is a phase I trial evaluating the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers.
Who can participate
Age range65 Years – 89 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
Determination of Maximum Plasma Concentration [Cmax] of IRL757
Timeframe: PK followed until 48 hours
2
Determination of the AUC of IRL757 and Its Main Metabolites
Timeframe: PK followed until 48 hours
3
Determination of the Time for Maximum Concentration [Tmax] of IRL757 and Its Main Metabolites
Timeframe: PK followed until 48 hours
4
Determination of the Half-life [t1/2] of IRL757 and Its Main Metabolites
Timeframe: PK followed until 48 hours
5
Determination of the Renal Clearance (CLr) of IRL757