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
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|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.
- Number and frequency of adverse events [ Time Frame: Up to Day 13 ]Standard clinical safety assessments
- Number of subjects with adverse events [ Time Frame: Up to Day 13 ]Adverse event monitoring
- Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau) [ Time Frame: Day 9 ]
- Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf) [ Time Frame: Day 1 ]
- Maximum observed concentration (Cmax) and time of observation (tmax) [ Time Frame: Day 1 and Day 9 ]
- Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½) [ Time Frame: Day 1 and Day 9 ]
- Accumulation index following multiple dosing of Lu AE58054 (AI) [ Time Frame: Day 9 ]
- 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
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
|London, United Kingdom, NW10 7EW|
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|