Absolute Bioavailability of Lu AE58054 in Healthy Subjects

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AE58054

Study type: Interventional

Funder types: Industry

Identifiers

NCT02019394

2012-005646-37 (EudraCT Number)

14915A

Details and patient eligibility

About

To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state

Enrollment: 10 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).
• The subjects CYP2D6 genotype must be determined before inclusion into the study.
• Women must not be pregnant or lactating.

Exclusion criteria

• The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Trial design

10 participants in 1 patient group

Lu AE58054

Experimental group

Treatment:

Drug: Lu AE58054