Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

• Status: Completed
• Trial end date: 2020-07-28
• Target enrollment: 0
• Participant gender: All

Summary

A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

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

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Itraconazole

Criteria

Inclusion Criteria:

• The subject has a BMI ≥18.5 and ≤30 kg/m2

• The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

• The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.

Exclusion Criteria:

• The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.

Other in- and exclusion criteria may apply