Skip to main content
OpenTrials
Completed

NCT Number: NCT01975779

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GB001

London, NW10 7EW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort A1: Lu AE58054 or placebo

Drug

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 placebo

Drug

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 AE58054

Drug

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

Primary outcomes

  1. Number and frequency of adverse events

    Time frame: Up to Day 13

    Standard clinical safety assessments

  2. Number of subjects with adverse events

    Time frame: Up to Day 13

    Adverse event monitoring

Secondary outcomes

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

    Time frame: Day 9

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

    Time frame: Day 1

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

    Time frame: Day 1 and Day 9

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

    Time frame: Day 1 and Day 9

  5. Accumulation index following multiple dosing of Lu AE58054 (AI)

    Time frame: Day 9

  6. Risk of Suicidality

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
First posted
Nov 5, 2013
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.