Study Investigating the Safety and Tolerability of 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04082325

Enrollment

Registered

2019-09-09

Start date

2019-07-23

Completion date

2020-09-24

Last updated

2021-02-24

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

Conditions

Healthy

Brief summary

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

Interventions

DRUGLu AF88434

Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

DRUGLu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Oral solution

DRUGLu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)

Oral solution

DRUGPlacebo

Placebo to Lu AF88434 oral solution, single dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

-Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.

Exclusion criteria

* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. * For Part B: The subject has received radiolabelled material \<12 months prior to the Screening Visit. Other inclusion and

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-emergent adverse events	From screening to Day 11	Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)
Cmax Lu AF88434	From 0 to 96 hours	Maximum observed plasma concentration
AUC(0-inf) Lu AF88434	From 0 to 96 hours	Area under the plasma concentration time curve from zero to infinity
CL/F Lu AF88434	From day 1 to day 5	Oral clearance for Lu AF88434 in plasma
Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)	From 0 to Day 14	—
Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)	From 0 to Day 14	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026