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Completed

NCT Number: NCT02953132

A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 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

Pharmaceutical Research Associates (PRA) Health Sciences

City Name, Netherlands

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, neurological, 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-4129

Drug

Placebo

Drug

Primary outcomes

  1. Safety and Tolerability as measured by incidence and severity of adverse events

    Time frame: Up to Day 14

  2. Safety and Tolerability as measured by vital signs

    Time frame: Up to Day 14

  3. Safety and Tolerability as measured by ECG

    Time frame: Up to Day 14

  4. Safety and Tolerability as measured by clinical laboratory assessments

    Time frame: Up to Day 14

  5. Safety and Tolerability as measured by Hormone assessments

    Time frame: Up to Day 10

  6. Safety and Tolerability as measured by physical examination

    Time frame: Up to Day 14

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of MT-4129

    Time frame: Up to Day 10

  2. Measured time of maximum observed plasma concentration (tmax) of MT-4129

    Time frame: Up to Day 10

  3. Apparent terminal elimination half-life (t1/2) of MT-4129

    Time frame: Up to Day 10

  4. AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129

    Time frame: Up to Day 8

  5. AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129

    Time frame: Up to Day 9

  6. AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129

    Time frame: Up to Day 10

  7. AUC from time zero to infinity (AUC0-∞) of MT-4129

    Time frame: Up to Day 10

  8. AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129

    Time frame: Up to Day 10

  9. AUC over the dosing interval (AUC0-t) of MT-4129

    Time frame: Up to Day 10

  10. Terminal elimination rate constant (Kel) of MT-4129

    Time frame: Up to Day 10

  11. Mean residence time (MRT) of MT-4129

    Time frame: Up to Day 10

  12. Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129

    Time frame: Up to Day 10

  13. Apparent volume of distribution at steady state (Vss/F) of MT-4129

    Time frame: Up to Day 10

  14. Apparent oral clearance (CL/F) of MT-4129

    Time frame: Up to Day 10

  15. Urinary excreted amount of test compound (Ae) of MT-4129

    Time frame: Up to Day 10

  16. Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129

    Time frame: Up to Day 10

  17. Renal clearance (CLR) of MT-4129

    Time frame: Up to Day 10

  18. Plasma aldosterone

    Time frame: Up to Day 10

  19. Serum cortisol

    Time frame: Up to Day 10

  20. Plasma steroid hormones

    Time frame: Up to Day 10

  21. Urinary aldosterone

    Time frame: Up to Day 10

  22. Urinary cortisol

    Time frame: Up to Day 10

  23. Urinary sodium

    Time frame: Up to Day 10

  24. Urine potassium

    Time frame: Up to Day 10

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-4129 in Healthy Subjects; Including the Effect of Gender and Age on the Pharmacokinetics of a Single Dose of MT-4129 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
May 18, 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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