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

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Aluminum Hydroxide; Antacids; Magnesium Hydroxide

Criteria

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.