Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).

Inclusion Criteria:

Subjects are eligible for inclusion into the study if they meet each of the following criteria:

• Men and women, aged 18 - 45 years.
• Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
• Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
• Non-childbearing potential or use of contraception (both sexes).
• Women must not be pregnant or lactating.
• Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .

Other Inclusion and Exclusion Criteria may apply.