Interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending-oral-dose study investigating the safety, tolerability, pharmacokinetic, and pharmacodynamic properties of Lu AF88434 and open-label crossover study to investigate the intra-individual variability, metabolic profile, and effect of food on Lu AF88434 in healthy young me
Completed
- Conditions
- psychiatric and neurologicalneurological diseasespsychiatric diseases
- Registration Number
- NL-OMON48259
- 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 with 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. Safety and<br /><br>tolerability based on the safety assessments (clinical safety laboratory tests,<br /><br>vital signs, weight, ECG parameters).<br /><br>2. Cmax Lu AF88434. Maximum observed plasma concentration.<br /><br>3. AUC(0-inf) Lu AF88434. Area under the plasma concentration time curve from<br /><br>zero to infinity.<br /><br>4. CL/F Lu AF88434. Oral clearance for Lu AF88434 in plasma.<br /><br>5. Total amount of radioactivity excreted.<br /><br>6. Total recovery of the administered dose (% of dose in urine and faeces).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable. </p><br>