*An interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study investigating the safety, tolerability, pharmacokinetic and pharmacodynamic properties of Lu AF95245 and open-label crossover study to investigate intra-subject variability, effect of food on Lu AF95245, and metabolic profile of [14C]-Lu AF95245 in healthy young men*
Completed
- Conditions
- psychiatric as well as neurological indicationsneurological diseasespsychiatric diseases
- Registration Number
- NL-OMON48207
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
Healthy, young, non-smoking men *18 and *45 years of age and a body mass index
(BMI) *18.5kg/m2 and *30kg/m2 at the Screening Visit.
Please refer to the protocol for more inclusion criteria.
Exclusion Criteria
The subject has any concurrent disorder that may affect the particular target
or absorption, distribution, or elimination of the IMP.
Please refer to the protocol for more exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Number of participants with treatment-emergent adverse events<br /><br>Safety and tolerability based on the safety assessments (clinical safety<br /><br>laboratory tests, vital signs, weight, ECG<br /><br>parameters and physical examination)<br /><br>2. AUC(0-inf) Lu AF95245<br /><br>Area under the plasma concentration time curve from zero to infinity<br /><br>3. Cmax Lu AF95245<br /><br>Maximum observed plasma concentration<br /><br>4. CL/F Lu AF95245<br /><br>Oral clearance for Lu AF95245 in plasma<br /><br>5. Total recovery of the administered dose (% of dose in urine and<br /><br>faeces)<br /><br>Excretion of labelled Lu AF95245 in urine and faeces</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>