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 men

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 men - 18144A Lundbeck (190100)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48259

Enrollment

Registered

2019-07-16

Start date

2019-08-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

psychiatric and neurological neurological diseases psychiatric diseases

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)