An open-label, one-sequence crossover interaction study investigating the effect of multiple doses of Lu AE58054 on cytochrome P450 3A4 and 2D6 activity measured by midazolam and dextromethorphan pharmacokinetics in healthy young men

An open-label, one-sequence crossover interaction study investigating the effect of multiple doses of Lu AE58054 on cytochrome P450 3A4 and 2D6 activity measured by midazolam and dextromethorphan pharmacokinetics in healthy young men - 12743A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34119

Enrollment

Registered

2010-09-03

Start date

2010-09-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Cognitive Impairment Associated with Schizophrenia and Alzheimer's disease

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 during medical research

Design outcomes

Primary

Measure	Time frame
To investigate the effect of multiple doses research medication on PK parameters for Midazolam and Dextromethorphan..	—

Secondary

Measure	Time frame
To examine the safety and tolerability of the research medication	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)