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Safety and Tolerability of Lu AG06474 in Healthy Young Men

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05003687
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
15.9
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lu AG06474
  • Drug: Placebo
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Dec 2, 2022
Anticipated Study Completion Date :
Dec 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Single Dose of Lu AG06474 or Placebo

Participants will receive single oral dose of Lu AG06474 or placebo.

Drug: Lu AG06474
solution, orally (Parts A and B)

Drug: Placebo
solution, orally (Part A only)
Experimental: Part B: Repeated Dose of Lu AG06474 and Food Interaction

Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence: Sequence B1: Fed - Fasting- Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed

Drug: Lu AG06474
solution, orally (Parts A and B)

Outcome Measures

Primary Outcome Measures

  1. Parts A and B: Number of participants With Treatment-Emergent Adverse Events [From Baseline to Day 8]

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

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

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

  5. Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4 [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]) [From pre-dose to Day 4]

  7. Parts A and B: AUC0-inf of Lu AG06474 [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 [From pre-dose to Day 4]

    Maximum observed plasma concentration for Lu AG06474

  9. Parts A and B: Tmax of Lu AG06474 [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 [From pre-dose to Day 4]

    Apparent elimination half-life of Lu AG06474

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Sciences Miami Miami Florida United States 33126

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT05003687
Other Study ID Numbers:
  • 19702A
First Posted:
Aug 12, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2022