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

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.

Official 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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MT-4129
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose, MT-4129 or Placebo<br> | Drug: MT-4129<br> <br> Drug: Placebo<br> <br> |
| Experimental: Multiple ascending dose, MT-4129 or Placebo<br> | Drug: MT-4129<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |