Safety and Tolerability of Lu AG06479 in Healthy Young Men

Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men

The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AG06479; Drug: Placebos

Detailed Description

Part A: randomized, sequential

Part B: open-label, cross-over

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Other in- and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: Single dose of Lu AG06479 or Placebo	Drug: Lu AG06479; capsules, orally (Part A and B); Other Names: ABX-1762; Drug: Placebos; Placebo - capsules, orally (Part A only)
EXPERIMENTAL: Part B: Repeated dose of Lu AG06479 and Food interaction; Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed	Drug: Lu AG06479; capsules, orally (Part A and B); Other Names: ABX-1762

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment emergent adverse events (Safety and Tolerability)	Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)	From baseline to Day 9 (Part A and B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC (0-inf) of Lu AG06479	Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)	From pre-dose to Day 5 (Part A and B)
CL/F Lu AG06479	Oral clearance of Lu AG06479	From pre-dose to Day 5 (Part A and B)
Cmax Lu AG06479	Maximum observed plasma concentration for Lu AG06479	From pre-dose to Day 5 (Part A and B)

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2020
• Primary Completion (ACTUAL): November 10, 2021
• Study Completion (ACTUAL): November 10, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 18452A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No