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Clinical Trials/NCT02953132
NCT02953132CompletedPhase 1

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

Mitsubishi Tanabe Pharma Corporation1 site in 1 country116 target enrollmentStarted: November 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
116
Locations
1
Primary Endpoint
Safety and Tolerability as measured by incidence and severity of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Multiple ascending dose, MT-4129 or Placebo

Experimental

Intervention: Placebo (Drug)

Single ascending dose, MT-4129 or Placebo

Experimental

Intervention: MT-4129 (Drug)

Single ascending dose, MT-4129 or Placebo

Experimental

Intervention: Placebo (Drug)

Multiple ascending dose, MT-4129 or Placebo

Experimental

Intervention: MT-4129 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Up to Day 14

Safety and Tolerability as measured by vital signs

Time Frame: Up to Day 14

Safety and Tolerability as measured by ECG

Time Frame: Up to Day 14

Safety and Tolerability as measured by clinical laboratory assessments

Time Frame: Up to Day 14

Safety and Tolerability as measured by Hormone assessments

Time Frame: Up to Day 10

Safety and Tolerability as measured by physical examination

Time Frame: Up to Day 14

Secondary Outcomes

  • Maximum observed plasma concentration (Cmax) of MT-4129(Up to Day 10)
  • Measured time of maximum observed plasma concentration (tmax) of MT-4129(Up to Day 10)
  • Apparent terminal elimination half-life (t1/2) of MT-4129(Up to Day 10)
  • AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129(Up to Day 8)
  • AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129(Up to Day 9)
  • AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129(Up to Day 10)
  • AUC from time zero to infinity (AUC0-∞) of MT-4129(Up to Day 10)
  • AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129(Up to Day 10)
  • AUC over the dosing interval (AUC0-t) of MT-4129(Up to Day 10)
  • Terminal elimination rate constant (Kel) of MT-4129(Up to Day 10)
  • Mean residence time (MRT) of MT-4129(Up to Day 10)
  • Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129(Up to Day 10)
  • Apparent volume of distribution at steady state (Vss/F) of MT-4129(Up to Day 10)
  • Apparent oral clearance (CL/F) of MT-4129(Up to Day 10)
  • Urinary excreted amount of test compound (Ae) of MT-4129(Up to Day 10)
  • Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129(Up to Day 10)
  • Renal clearance (CLR) of MT-4129(Up to Day 10)
  • Plasma aldosterone(Up to Day 10)
  • Serum cortisol(Up to Day 10)
  • Plasma steroid hormones(Up to Day 10)
  • Urinary aldosterone(Up to Day 10)
  • Urinary cortisol(Up to Day 10)
  • Urinary sodium(Up to Day 10)
  • Urine potassium(Up to Day 10)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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