This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing singleoral doses.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychiatric and neurological
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Number of participants with treatment-emergent adverse events. Safety and
tolerability based on the safety assessments (clinical safety laboratory tests,
vital signs, weight, ECG parameters).
2. Cmax Lu AF88434. Maximum observed plasma concentration.
3. AUC(0-inf) Lu AF88434. Area under the plasma concentration time curve from
zero to infinity.
4. CL/F Lu AF88434. Oral clearance for Lu AF88434 in plasma.
5. Total amount of radioactivity excreted.
6. Total recovery of the administered dose (% of dose in urine and faeces).
Secondary outcome
Not applicable.
Background summary
This study is the first clinical study to be conducted with Lu AF88434. Part A
has been designed to investigate the safety, tolerability, and pharmacokinetic
and pharmacodynamic properties of Lu AF88434 following single, ascending oral
doses administered to healthy young men. Part B has been designed to
investigate the intra-individual variability and potential effect of food, as
well as investigating mass balance and metabolite profile, using 14C-labelled
Lu AF88434. The data obtained in this study will provide the basis for the
further clinical development of Lu AF88434.
Study objective
This study evaluates the effect of Lu AF88434 on the body and what the body
does to Lu AF88434 and the effect of food after swallowing single
oral doses.
Study design
This is the first study in humans with Lu AF88434. It consists of an
interventional, randomized, double-blind, sequential-group, placebo-controlled,
single-ascending-oral-dose part, followed by an open-label crossover part
including a radiolabelled spike.
The study will comprise of two parts: Parts A and B; the dose in Part B will be
based on data from Part A.
The study design is presented in
Panel 1 and the scheduled study procedures and assessments are summarized in
Panel 2 and Panel 3 for Part A and Part B, respectively (please refer to the
protocol for the panels).
Safety and tolerability will be assessed throughout the study. The
pharmacokinetic properties of Lu AF88434 will be based on plasma concentration
data. For Groups B1 and B2 in Part B, all excreta will be collected in the
treatment period the subjects receive the [14C]-labelled spike.
Intervention
Lu AF88434 oral solution
Placebo oral solution
Lu AF99723 ([triazolemethylene-14C]-Lu AF88434) oral solution
Lu AF99722 ([ethoxypyridyl-2,6-14C]-Lu AF88434) oral solution
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IMPD for further information.
Ottiliavej 9
Valby 2500
DK
Ottiliavej 9
Valby 2500
DK
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003561-34-NL |
| CCMO | NL70222.056.19 |