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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

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.