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

Lundbeck

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Itraconazole

Drug: Lu AE58054 30 mg + itraconazole 200 mg

Drug: Lu AE58054 30 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02122692

15820A

2013-003597-27 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.