Safety and Tolerability of Lu AG06479 in Healthy Young Men

Phase 1TerminatedNCT04473651

H. Lundbeck A/S46 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Lu AG06479DRUG

capsules, orally (Part A and B)

PlacebosDRUG

Placebo - capsules, orally (Part A only)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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)

Time frame: From baseline to Day 9 (Part A and B)

Secondary Outcomes

AUC (0-inf) of Lu AG06479

Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)

Time frame: From pre-dose to Day 5 (Part A and B)

CL/F Lu AG06479

Oral clearance of Lu AG06479

Time frame: From pre-dose to Day 5 (Part A and B)

Cmax Lu AG06479

Maximum observed plasma concentration for Lu AG06479

Time frame: From pre-dose to Day 5 (Part A and B)

Data from ClinicalTrials.gov

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