The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Hammersmith Medicines Research
London, United Kingdom
Number of subjects with TEAEs and number of events will be summarised by treatment
Adverse Events after treatment administration will be collected at baseline and repeated until study completion
Time frame: 33 (group 1) or 35 (group 2) days
Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment
Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21
Time frame: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21
Time frame: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21.
Time frame: 19 (group 1) or 21 (group 2) days
Number of subjects with PCI abnormal vital sign variables will be summarised by treatment
Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21
Time frame: 19 (group 1) or 21 (group 2) days
Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)
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Ctrough will be measured after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Maximum (peak) blood concentration (Cmax)
Cmax will be calculated after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Terminal half life (t1/2)
t1/2 will be calculated after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)
AUCt will be calculated after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: Apparent total body clearance from blood (CLss)
CLss will be calculated after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days
PK of IRL201104: steady state volume of distribution (Vz)
Vz will be calculated after multiple dosing
Time frame: 5 (group 1) or 7 (group 2) days