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

NCT ID: NCT01975779

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A1: Lu AE58054 or placebo

Group Type EXPERIMENTAL

Cohort A1: Lu AE58054 or placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Cohort A2: Lu AE58054 or placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Cohort B1: Lu AE58054

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Cohort B1: Lu AE58054

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB001

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-005648-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14917A

Identifier Type: -

Identifier Source: org_study_id