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

Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cohort A1: Lu AE58054 or placebo; Drug: Cohort A2: Lu AE58054 or placebo; Drug: Cohort B1: Lu AE58054

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • GB001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A1: Lu AE58054 or placebo	Drug: Cohort A1: Lu AE58054 or placebo; One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.
Experimental: Cohort A2: Lu AE58054 or placebo	Drug: Cohort A2: Lu AE58054 or placebo; One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.
Experimental: Cohort B1: Lu AE58054	Drug: Cohort B1: Lu AE58054; Two single oral doses 60 mg with >=7 days washout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and frequency of adverse events	Standard clinical safety assessments	Up to Day 13
Number of subjects with adverse events	Adverse event monitoring	Up to Day 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)		Day 9
Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)		Day 1
Maximum observed concentration (Cmax) and time of observation (tmax)		Day 1 and Day 9
Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)		Day 1 and Day 9
Accumulation index following multiple dosing of Lu AE58054 (AI)		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	Up to Day 13

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 14917A; 2012-005648-10 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No