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Completed

NCT Number: NCT04082325

Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

QPS

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria may apply

Treatment and study plan

Lu AF88434

Drug

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).

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

Drug

Oral solution

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

Drug

Oral solution

Placebo

Drug

Placebo to Lu AF88434 oral solution, single dose

Primary outcomes

  1. Number of participants with treatment-emergent adverse events

    Time frame: From screening to Day 11

    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)

  2. Cmax Lu AF88434

    Time frame: From 0 to 96 hours

    Maximum observed plasma concentration

  3. AUC(0-inf) Lu AF88434

    Time frame: From 0 to 96 hours

    Area under the plasma concentration time curve from zero to infinity

  4. CL/F Lu AF88434

    Time frame: From day 1 to day 5

    Oral clearance for Lu AF88434 in plasma

  5. Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)

    Time frame: From 0 to Day 14

  6. Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)

    Time frame: From 0 to Day 14

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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