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Completed

NCT Number: NCT05003687

Safety and Tolerability of Lu AG06474 in Healthy Young Men

The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.

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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

Quotient Sciences Miami

Miami, Florida, 33126, United States

About this study

Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Safety Baseline/Baseline Visit.
  • The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion criteria

  • The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
  • The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit.
  • The participant has a QTcF interval >450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator.
  • The participant has taken any investigational medicinal product <3 months prior to the first dose of study drug.
  • The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug.

Other inclusion and exclusion criteria may apply.

Treatment and study plan

Lu AG06474

Drug

solution, orally (Parts A and B)

Placebo

Drug

solution, orally (Part A only)

Primary outcomes

  1. Parts A and B: Number of participants With Treatment-Emergent Adverse Events

    Time frame: From Baseline to Day 8

  2. Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1

    Time frame: Day 1

  3. Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1

    Time frame: Pre-dose Baseline (Day -1), Day 1

  4. Part A: Bond-Lader VAS Dimension Scores at Day 4

    Time frame: Day 4

  5. Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4

    Time frame: Pre-dose Baseline (Day -1), Day 4

  6. Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA])

    Time frame: From pre-dose to Day 4

  7. Parts A and B: AUC0-inf of Lu AG06474

    Time frame: From pre-dose to Day 4

    Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)

  8. Parts A and B: Cmax of Lu AG06474

    Time frame: From pre-dose to Day 4

    Maximum observed plasma concentration for Lu AG06474

  9. Parts A and B: Tmax of Lu AG06474

    Time frame: From pre-dose to Day 4

    Nominal time corresponding to the occurrence of Cmax of Lu AG06474

  10. Part A: t1/2 of Lu AG06474

    Time frame: From pre-dose to Day 4

    Apparent elimination half-life of Lu AG06474

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 AG06474 and Open-Label, Cross-Over Study to Investigate Intra-Subject Variability and the Effect of Food in Healthy Young Men

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Jan 9, 2023

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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