Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cohort A2: Lu AE58054 or placebo; Drug: Cohort A1: Lu AE58054 or placebo; Drug: Cohort B1: Lu AE58054

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975779

14917A

2012-005648-10 (EudraCT Number)

Details and patient eligibility

About

To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.

Full description

The study will be conducted in two parts.

Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.

Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.

Enrollment: 42 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).

Exclusion criteria

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

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

42 participants in 3 patient groups

Cohort A1: Lu AE58054 or placebo

Experimental group

Treatment:

Drug: Cohort A1: Lu AE58054 or placebo

Cohort A2: Lu AE58054 or placebo

Experimental group

Treatment:

Drug: Cohort A2: Lu AE58054 or placebo

Cohort B1: Lu AE58054

Experimental group

Treatment:

Drug: Cohort B1: Lu AE58054