A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

January 4, 2016 updated by: Mitsubishi Tanabe Pharma Corporation
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy and free from clinically significant illness or disease
  • Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
  • A body weight of ≥60 kg male and ≥50 kg female

Exclusion Criteria:

  • Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
  • Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
  • Clinically relevant abnormal medical history, physical findings or laboratory values

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single ascending dose, MT-8554 or Placebo
Drug: Placebo
Drug: MT-8554
Experimental: Multiple ascending dose, MT-8554 or Placebo
Drug: Placebo
Drug: MT-8554

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as measured by vital signs
Time Frame: up to Day14
up to Day14
Safety and Tolerability as measured by ECG
Time Frame: up to Day14
up to Day14
Safety and Tolerability as measured by continuous lead II ECG monitoring
Time Frame: up to Day14
up to Day14
Safety and Tolerability as measured by laboratory safety assessments
Time Frame: up to Day14
up to Day14
Safety and Tolerability as measured by physical examination
Time Frame: up to Day14
up to Day14
Safety and Tolerability as measured by number of participants with adverse events
Time Frame: up to Day14
up to Day14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK profile (Cmax, tmax, t½, AUC)
Time Frame: 240 hours post dose
Cmax, tmax, t½, AUC
240 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MT-8554-E01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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