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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: MT-4129

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • City Name, Netherlands
    • Pharmaceutical Research Associates (PRA) Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single ascending dose, MT-4129 or Placebo	Drug: Placebo; Drug: MT-4129
Experimental: Multiple ascending dose, MT-4129 or Placebo	Drug: Placebo; Drug: MT-4129

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability as measured by incidence and severity of adverse events	Up to Day 14
Safety and Tolerability as measured by vital signs	Up to Day 14
Safety and Tolerability as measured by ECG	Up to Day 14
Safety and Tolerability as measured by clinical laboratory assessments	Up to Day 14
Safety and Tolerability as measured by Hormone assessments	Up to Day 10
Safety and Tolerability as measured by physical examination	Up to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MT-4129-E01