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

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ClinicalTrials.gov Identifier: NCT01975779
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2013
Actual Primary Completion Date : October 2013

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975779


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

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01975779     History of Changes
Other Study ID Numbers: 14917A
2012-005648-10 ( EudraCT Number )
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: October 2013