Healthy
Conditions
Brief summary
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
Interventions
DRUGPlacebo
Placebo to Lu AF76432 oral solution
DRUGLu AF76432
Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.
Exclusion criteria
* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason * The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events | From dosing to 12 days | Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | From dosing to 72 hours post dose | Area under the plasma concentration-time curve from zero to time t |
| Cmax | From dosing to 72 hours post dose | Maximum observed concentration |
| AUC0-inf | From dosing to 72 hours post dose | Area under the plasma concentration-time curve from zero to infinity |
| CL/F | From dosing to 72 hours post dose | Oral clearance |
Countries
United Kingdom
Outcome results
None listed