The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
solution, orally (Parts A and B)
solution, orally (Part A only)
Quotient Sciences Miami
Miami, Florida, United States
Parts A and B: Number of participants With Treatment-Emergent Adverse Events
Time frame: From Baseline to Day 8
Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1
Time frame: Day 1
Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1
Time frame: Pre-dose Baseline (Day -1), Day 1
Part A: Bond-Lader VAS Dimension Scores at Day 4
Time frame: Day 4
Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4
Time frame: Pre-dose Baseline (Day -1), Day 4
Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA])
Time frame: From pre-dose to Day 4
Parts A and B: AUC0-inf of Lu AG06474
Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: From pre-dose to Day 4
Parts A and B: Cmax of Lu AG06474
Maximum observed plasma concentration for Lu AG06474
Time frame: From pre-dose to Day 4
Parts A and B: Tmax of Lu AG06474
Nominal time corresponding to the occurrence of Cmax of Lu AG06474
Time frame: From pre-dose to Day 4
Part A: t1/2 of Lu AG06474
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Apparent elimination half-life of Lu AG06474
Time frame: From pre-dose to Day 4