Healthy
Conditions
Brief summary
To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.
Detailed description
The study will be conducted in two parts. Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men. Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.
Interventions
DRUGCohort A1: Lu AE58054 or placebo
One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.
DRUGCohort A2: Lu AE58054 or placebo
One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.
DRUGCohort B1: Lu AE58054
Two single oral doses 60 mg with \>=7 days washout.
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).
Exclusion criteria
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and frequency of adverse events | Up to Day 13 | Standard clinical safety assessments |
| Number of subjects with adverse events | Up to Day 13 | Adverse event monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf) | Day 1 | — |
| Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½) | Day 1 and Day 9 | — |
| Maximum observed concentration (Cmax) and time of observation (tmax) | Day 1 and Day 9 | — |
| Risk of Suicidality | Up to Day 13 | Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A |
| Accumulation index following multiple dosing of Lu AE58054 (AI) | Day 9 | — |
| Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau) | Day 9 | — |
Countries
United Kingdom
Outcome results
None listed