MedTrace Logo

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

NCT01975779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-11-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

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.

DRUG

Cohort B1: Lu AE58054

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975779 on ClinicalTrials.gov