A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects

January 4, 2016 updated by: Mitsubishi Tanabe Pharma Corporation
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy and free from clinically significant illness or disease
  • Male Caucasian subjects aged 18 to 55
  • A body weight of ≥60 kg

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen 1
Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing
Drug: Placebo
Drug: MT-8554 low dose
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Experimental: Regimen 2
Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing
Drug: Placebo
Drug: MT-8554 low dose
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Experimental: Regimen 3
Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing
Drug: Placebo
Drug: MT-8554 low dose
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Experimental: Regimen 4
Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
Drug: Placebo
Drug: MT-8554 low dose
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
Time Frame: up to 10 hours post dosing
up to 10 hours post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as measured by vital signs
Time Frame: up to Day6 of treatment period 4
up to Day6 of treatment period 4
Safety and Tolerability as measured by ECG
Time Frame: up to Day6 of treatment period 4
up to Day6 of treatment period 4
Safety and Tolerability as measured by laboratory safety assessments
Time Frame: up to Day6 of treatment period 4
up to Day6 of treatment period 4
Safety and Tolerability as measured by physical examination
Time Frame: up to Day6 of treatment period 4
up to Day6 of treatment period 4
Safety and Tolerability as measured by number of participants with adverse events
Time Frame: up to Day6 of treatment period 4
up to Day6 of treatment period 4
Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments
Time Frame: up to 10 hours post dosing
up to 10 hours post dosing
Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments
Time Frame: up to 10 hours post dosing
up to 10 hours post dosing

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

August 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 31, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-8554-E03

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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