Safety and Tolerability of Lu AG06479 in Healthy Young Men

Lundbeck

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AG06479; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04473651

18452A

Details and patient eligibility

About

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.

Full description

Part A: randomized, sequential

Part B: open-label, cross-over

Enrollment: 46 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Part A: Single dose of Lu AG06479 or Placebo

Experimental group

Treatment:

Drug: Placebos

Drug: Lu AG06479

Part B: Repeated dose of Lu AG06479 and Food interaction

Experimental group

Description:

Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed

Treatment:

Drug: Lu AG06479