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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975779
• Other study ID #: 14917A
• Secondary ID: 2012-005648-10
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2013
• Last updated: October 29, 2013
• Start date: July 2013

Study information

• Verified date: October 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• Cohort B1: Lu AE58054
Two single oral doses 60 mg with >=7 days washout.

Locations

Country	Name	City	State
United Kingdom	GB001	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and frequency of adverse events	Standard clinical safety assessments	Up to Day 13	Yes
Primary	Number of subjects with adverse events	Adverse event monitoring	Up to Day 13	Yes
Secondary	Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)		Day 9	No
Secondary	Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)		Day 1	No
Secondary	Maximum observed concentration (Cmax) and time of observation (tmax)		Day 1 and Day 9	No
Secondary	Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)		Day 1 and Day 9	No
Secondary	Accumulation index following multiple dosing of Lu AE58054 (AI)		Day 9	No
Secondary	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	Yes