A Single-centre, Open-label, Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers
Phase: PHASE1
Conditions: Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy
Sponsor: Integrative Research Laboratories AB

 
CONFIDENTIAL                                         1 (60)                         IRL757C002 Clinical Trial Protocol 
 
 
V2.1_02-OCT-2024  
 
 
 
 
 
CONFIDENTIAL 
 
A single-centre, open-label, phase I trial evaluating the pharmacokinetics of 
single ascending oral doses of IRL757 in healthy elderly volunteers. 
 
PROTOCOL SYNOPSIS 
 
Version: 
2.1  
Version date: 
02-OCT-2024 
Superseded version: 
Not applicable 
Sponsor: 
Integrative Research Laboratories Sweden AB 
(IRLAB) 
Product: 
IRL757 
 
Trial Number(s): 
IRL757C002 
EU trial no: 2024-515124-36-00 
NCT no: NCT06699628  
 
 
Integrative Research Laboratories Sweden AB (IRLAB) 
Arvid Wallgrens Backe 20 
413 46 Göteborg 
SWEDEN 
 
Phone: +46 (0)70 760 16 91 
 
 

 
CONFIDENTIAL                                         4 (60)                         IRL757C002 Clinical Trial Protocol 
 
 
V2.1_02-OCT-2024  
 
All statistical calculations will be performed using the SAS® version 9.4 or later (SAS Institute Inc., 
Cary, NC, USA). The statistical analyses will only include descriptive statistics reflecting the 
explorative nature of the trial. In general, the data will be presented by dose group.  
Continuous data will be summarised by dose group using number of observations, mean, standard 
deviation (SD), median, minimum and maximum. Categorical data will be summarised by dose group 
using the number and percentage of subjects in each category. 
Unless otherwise stated, statistical evaluations will be based on all subjects who have received 
treatment with IMP. The Full Analysis Set (FAS) data set will be used for the safety, tolerability 
assessments and description of trial population. 
The Pharmacokinetic Analysis Set (PKAS) comprises data from all subjects who received IMP, who 
provided an evaluable plasma concentration profile and who have no AEs or protocol deviations 
judged to affect the PK analysis. Individual PK values may be excluded from the analysis as specified 
in the SAP.  
The PK parameters will be calculated by non-compartmental analysis (NCA) using the software 
Phoenix WinNonlin® version 8.3 or later (Certara, USA).