Absolute Bioavailability of Lu AE58054 in Healthy Subjects
- Registration Number
- NCT02019394
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).
- The subjects CYP2D6 genotype must be determined before inclusion into the study.
- Women must not be pregnant or lactating.
Exclusion Criteria
- The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lu AE58054 Lu AE58054 -
- Primary Outcome Measures
Name Time Method Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV Day 10 Intravenous (IV)
Ratio of (AUC0-24(PM)/AUC0-24(EM)) Day 10 Poor Metaboliser (PM); Extensive Metaboliser (EM)
- Secondary Outcome Measures
Name Time Method Number and frequency of adverse events Up to Day 16 Standard clinical safety assessments
Number of subjects with adverse events Up to Day 16 Adverse event monitoring
Risk of Suicidality Up to Day 16 Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions
Trial Locations
- Locations (1)
GB803
🇬🇧Nottingham, United Kingdom
GB803🇬🇧Nottingham, United Kingdom