Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug
Detailed description
The study is divided in two parts, Part A and Part B: Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men. Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3) Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.
Interventions
DRUGLu AF95245
solution, single dose, orally
DRUGLu AF95245 14C radiolabelled spiked dosage
solution, single dose, orally
DRUGPlacebo
solution, single dose, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Cohort A: sequential, cohort B parallel
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, young, non-smoking men with a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
Exclusion criteria
* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP. Other in- and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events | From baseline to Day 14 | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) |
| AUC(0-inf) Lu AF95245 | From 0 to 96 hours | Area under the plasma concentration time curve from zero to infinity |
| Cmax Lu AF95245 | From 0 to 96 hours | Maximum observed plasma concentration |
| CL/F Lu AF95245 | From 0 to 96 hours | Oral clearance for Lu AF95245 in plasma |
| Total recovery of the administered dose (% of dose in urine and faeces) | From 0 to Day 14 | Excretion of labelled Lu AF95245 in urine and faeces |
Countries
Netherlands
Outcome results
None listed