Trial record 1 of 8 for:    Lu AE58054
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Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01975779
First received: October 29, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Cohort A1: Lu AE58054 or placebo
Drug: Cohort A2: Lu AE58054 or placebo
Drug: Cohort B1: Lu AE58054
Phase 1

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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Number and frequency of adverse events [ Time Frame: Up to Day 13 ] [ Designated as safety issue: Yes ]
    Standard clinical safety assessments

  • Number of subjects with adverse events [ Time Frame: Up to Day 13 ] [ Designated as safety issue: Yes ]
    Adverse event monitoring


Secondary Outcome Measures:
  • Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau) [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
  • Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) and time of observation (tmax) [ Time Frame: Day 1 and Day 9 ] [ Designated as safety issue: No ]
  • Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½) [ Time Frame: Day 1 and Day 9 ] [ Designated as safety issue: No ]
  • Accumulation index following multiple dosing of Lu AE58054 (AI) [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
  • Risk of Suicidality [ Time Frame: Up to Day 13 ] [ Designated as safety issue: Yes ]
    Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A


Enrollment: 42
Study Start Date: July 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975779

Locations
United Kingdom
GB001
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01975779     History of Changes
Other Study ID Numbers: 14917A, 2012-005648-10
Study First Received: October 29, 2013
Last Updated: October 29, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on April 17, 2014