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

*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* - CS0329 Lundbeck (18193A)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48207

Enrollment

Registered

2019-11-25

Start date

2020-01-13

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 as well as neurological indications neurological diseases psychiatric diseases

Interventions

Lu AF95425

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 and physical examination) 2. AUC(0-inf) Lu AF95245 Area under the plasma concentration time curve from zero to infinity 3. Cmax Lu AF95245 Maximum observed plasma concentration 4. CL/F Lu AF95245 Oral clearance for Lu AF95245 in plasma 5. Total recovery of the administered dose (% of dose in urine and faeces) Excretion of labelled Lu AF95245 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 and physical examination) 2. AUC(0-inf) Lu AF95245 Area under the plasma concentration time curve from zero to infinity 3. Cmax Lu AF95245 Maximum observed plasma concentration 4. CL/F Lu AF95245 Oral clearance for Lu AF95245 in plasma 5. Total recovery of the administered dose (% of dose in urine and faeces) Excretion of labelled Lu AF95245 in urine and faeces

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)