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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01975779
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

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 Timeline

• Study Start: 2013-07
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Last Update Submitted: 2013-10-29
• Study First Posted: 2013-11-05
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Up to Day 13	Adverse event monitoring
Number and frequency of adverse events	Up to Day 13	Standard clinical safety assessments

Secondary Outcome Measures

Name	Time	Method
Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)	Day 9
Risk of Suicidality	Up to Day 13	Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A
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

Trial Locations

Locations (1)

GB001; 🇬🇧 London, United Kingdom