NCT01975779

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
Last Updated

November 5, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

October 29, 2013

Last Update Submit

October 29, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Number and frequency of adverse events

    Standard clinical safety assessments

    Up to Day 13

  • Number of subjects with adverse events

    Adverse event monitoring

    Up to Day 13

Secondary Outcomes (6)

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

    Day 9

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

    Day 1

  • Maximum observed concentration (Cmax) and time of observation (tmax)

    Day 1 and Day 9

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

    Day 1 and Day 9

  • Accumulation index following multiple dosing of Lu AE58054 (AI)

    Day 9

  • +1 more secondary outcomes

Study Arms (3)

Cohort A1: Lu AE58054 or placebo

EXPERIMENTAL
Drug: Cohort A1: Lu AE58054 or placebo

Cohort A2: Lu AE58054 or placebo

EXPERIMENTAL
Drug: Cohort A2: Lu AE58054 or placebo

Cohort B1: Lu AE58054

EXPERIMENTAL
Drug: Cohort B1: Lu AE58054

Interventions

Cohort A1: Lu AE58054 or placeboDRUG

One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.

Cohort A1: Lu AE58054 or placebo
Cohort A2: Lu AE58054 or placeboDRUG

One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.

Cohort A2: Lu AE58054 or placebo
Cohort B1: Lu AE58054DRUG

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

Cohort B1: Lu AE58054

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB001

London, NW10 7EW, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 5, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-10

Locations

GB(1)