Clinical trial NCT05003687: Safety and Tolerability of Lu AG06474 in Healthy Young Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 79
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Parts A and B: Number of participants With Treatment-Emergent Adverse Events
timeFrame: From Baseline to Day 8
measure: Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1
timeFrame: Day 1
measure: Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1
timeFrame: Pre-dose Baseline (Day -1), Day 1
measure: Part A: Bond-Lader VAS Dimension Scores at Day 4
timeFrame: Day 4
measure: Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4
timeFrame: Pre-dose Baseline (Day -1), Day 4
measure: 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])
timeFrame: From pre-dose to Day 4
measure: Parts A and B: AUC0-inf of Lu AG06474
timeFrame: From pre-dose to Day 4
measure: Parts A and B: Cmax of Lu AG06474
timeFrame: From pre-dose to Day 4
measure: Parts A and B: Tmax of Lu AG06474
timeFrame: From pre-dose to Day 4
measure: Part A: t1/2 of Lu AG06474
timeFrame: From pre-dose to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: