Randomised, double-blind, sequential-group, placebo-controlled, single-ascending oral dose, interventional study, investigating the safety, tolerability, pharmacokinetics, pharmacodynamics and metabolite profile of Lu AF09535 in healthy young men, and an open-label crossover to study intra-subject variability and effects of food

Randomised, double-blind, sequential-group, placebo-controlled, single-ascending oral dose, interventional study, investigating the safety, tolerability, pharmacokinetics, pharmacodynamics and metabolite profile of Lu AF09535 in healthy young men, and an open-label crossover to study intra-subject variability and effects of food - 14221A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37456

Enrollment

Registered

2012-02-02

Start date

2012-02-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood disorders Mental disorder Mood disorders

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG, vital signs). Furthermore a blood

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics and pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)