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Completed

NCT Number: NCT02834442

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy 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

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 for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

Exclusion criteria

  • Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
  • Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin 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-7117

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: up to Day56

  2. Safety and Tolerability as measured by vital signs

    Time frame: up to Day56

  3. Safety and Tolerability as measured by physical examination

    Time frame: up to Day56

  4. Safety and Tolerability as measured by ECG

    Time frame: up to Day21

  5. Safety and Tolerability as measured by laboratory safety assessments

    Time frame: up to Day21

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 96 hours post dose

  2. Area under the plasma concentration-time curve (AUC)

    Time frame: 96 hours post dose

  3. Time to maximum plasma concentration (Tmax)

    Time frame: 96 hours post dose

  4. Apparent elimination half-life in plasma

    Time frame: 96 hours post dose

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Jul 25, 2017

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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