A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

H. Lundbeck A/S16 enrolled

Overview

The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.

This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lu AG06466 CapsuleDRUG

Hard capsule

Lu AG06466 TabletDRUG

Film-coated tablet

AntacidDRUG

Oral suspension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m\^2 at the Screening Visit and at the Baseline Visit. * The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit. Exclusion Criteria: * The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses). * The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion and exclusion criteria may apply.

Locations (1)

LabCorp Clinical Research Unit Ltd

Leeds, United Kingdom

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466

AUC(0-inf) is defined as AUC0-tlast + Clast \* t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life).