Safety and Tolerability of Lu AG06474 in Healthy Young Men

NCT05003687 | Completed Phase 1 FDA Drug

• 1 other identifier: 19702A
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

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

  From Baseline to Day 8

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

  Day 1

• 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

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

  Day 4

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

  Pre-dose Baseline (Day -1), Day 4

• 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

• 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

• Parts A and B: Cmax of Lu AG06474

  Maximum observed plasma concentration for Lu AG06474

  From pre-dose to Day 4

• 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

• Part A: t1/2 of Lu AG06474

  Apparent elimination half-life of Lu AG06474

  From pre-dose to Day 4

Study Arms (2)

Part A: Single Dose of Lu AG06474 or Placebo

EXPERIMENTAL

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

Drug: Lu AG06474; Drug: Placebo

Part B: Repeated Dose of Lu AG06474 and Food Interaction

EXPERIMENTAL

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

Interventions

Lu AG06474 DRUG

solution, orally (Parts A and B)

Part A: Single Dose of Lu AG06474 or Placebo; Part B: Repeated Dose of Lu AG06474 and Food Interaction

Placebo DRUG

solution, orally (Part A only)

Part A: Single Dose of Lu AG06474 or Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Quotient Sciences Miami

Miami, Florida, 33126, United States

Location

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: August 4, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

US (1)