Safety and Tolerability of Lu AG06474 in Healthy Young Men

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003687
• Other study ID #: 19702A
• Status: Completed
• Phase: Phase 1
• Start date: August 4, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: January 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AG06474
solution, orally (Parts A and B)
• Placebo
solution, orally (Part A only)

Locations

Country	Name	City	State
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts A and B: Number of participants With Treatment-Emergent Adverse Events		From Baseline to Day 8
Primary	Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1		Day 1
Primary	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
Primary	Part A: Bond-Lader VAS Dimension Scores at Day 4		Day 4
Primary	Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4		Pre-dose Baseline (Day -1), Day 4
Primary	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
Primary	Parts A and B: AUC0-inf of Lu AG06474	Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)	From pre-dose to Day 4
Primary	Parts A and B: Cmax of Lu AG06474	Maximum observed plasma concentration for Lu AG06474	From pre-dose to Day 4
Primary	Parts A and B: Tmax of Lu AG06474	Nominal time corresponding to the occurrence of Cmax of Lu AG06474	From pre-dose to Day 4
Primary	Part A: t1/2 of Lu AG06474	Apparent elimination half-life of Lu AG06474	From pre-dose to Day 4