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Completed

NCT Number: NCT02429102

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

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

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 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

Treatment and study plan

MT-8554

Drug

Placebo

Drug

Primary outcomes

  1. Safety and Tolerability as measured by vital signs

    Time frame: up to Day14

  2. Safety and Tolerability as measured by ECG

    Time frame: up to Day14

  3. Safety and Tolerability as measured by continuous lead II ECG monitoring

    Time frame: up to Day14

  4. Safety and Tolerability as measured by laboratory safety assessments

    Time frame: up to Day14

  5. Safety and Tolerability as measured by physical examination

    Time frame: up to Day14

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

    Time frame: up to Day14

Secondary outcomes

  1. PK profile (Cmax, tmax, t½, AUC)

    Time frame: 240 hours post dose

    Cmax, tmax, t½, AUC

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 29, 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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