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Completed

NCT Number: NCT02536209

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational center

City Name, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-8554 Low dose

Drug

MT-8554 High dose

Drug

Oxycodone hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test

    Time frame: up to 10 hours post dosing

Secondary outcomes

  1. Safety and Tolerability as measured by vital signs

    Time frame: up to Day6 of treatment period 4

  2. Safety and Tolerability as measured by ECG

    Time frame: up to Day6 of treatment period 4

  3. Safety and Tolerability as measured by laboratory safety assessments

    Time frame: up to Day6 of treatment period 4

  4. Safety and Tolerability as measured by physical examination

    Time frame: up to Day6 of treatment period 4

  5. Safety and Tolerability as measured by number of participants with adverse events

    Time frame: up to Day6 of treatment period 4

  6. Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments

    Time frame: up to 10 hours post dosing

  7. Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments

    Time frame: up to 10 hours post dosing

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2015
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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