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

NCT ID: NCT02536209

Last Updated: 2025-12-22

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

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The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Study Groups

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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

Group Type EXPERIMENTAL

MT-8554 low dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Oxycodone hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

MT-8554 low dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Oxycodone hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

MT-8554 low dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Oxycodone hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Group Type EXPERIMENTAL

MT-8554 low dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Oxycodone hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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MT-8554 low dose

Intervention Type DRUG

MT-8554 high dose

Intervention Type DRUG

Oxycodone hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational center

City Name, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MT-8554-E03

Identifier Type: -

Identifier Source: org_study_id