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

Phase 1CompletedNCT01975779

H. Lundbeck A/S42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Cohort A1: Lu AE58054 or placeboDRUG

One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.

Cohort A2: Lu AE58054 or placeboDRUG

One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.

Cohort B1: Lu AE58054DRUG

Two single oral doses 60 mg with \>=7 days washout.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GB001

London, United Kingdom

Outcomes

Primary Outcomes

Number and frequency of adverse events

Standard clinical safety assessments

Time frame: Up to Day 13

Number of subjects with adverse events

Adverse event monitoring

Time frame: Up to Day 13

Secondary Outcomes

Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)

Time frame: Day 9

Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)

Time frame: Day 1

Maximum observed concentration (Cmax) and time of observation (tmax)

Time frame: Day 1 and Day 9

Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)

Time frame: Day 1 and Day 9

Accumulation index following multiple dosing of Lu AE58054 (AI)

Time frame: Day 9

Risk of Suicidality

Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A

Time frame: Up to Day 13

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.