Safety and Tolerability of Lu AG06474 in Healthy Young Men

NCT ID: NCT05003687

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-12-22

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: Single Dose of Lu AG06474 or Placebo

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

Group Type: EXPERIMENTAL

Lu AG06474

Intervention Type: DRUG

solution, orally (Parts A and B)

Placebo

Intervention Type: DRUG

solution, orally (Part A only)

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

Group Type: EXPERIMENTAL

Lu AG06474

Intervention Type: DRUG

solution, orally (Parts A and B)

Interventions

Lu AG06474

solution, orally (Parts A and B)

Intervention Type: DRUG

Placebo

solution, orally (Part A only)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Quotient Sciences Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

19702A

Identifier Type: -

Identifier Source: org_study_id