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.

MT-4129 is a new investigational compound that may eventually be used for the
treatment of diseases associated with aldosterone. MT-4129 inhibits an enzyme
(protein) called aldosterone synthase (also called CYP11B2). Aldosterone
synthase is involved in the synthesis of aldosterone
in the adrenal cortex. Aldosterone plays an important role in the regulation of
blood pressure. Inhibition of aldosterone synthase is expected to be used in
the treatment for hypertension, heart failure and renal disorders. This is the
first time that MT-4129 is being given to humans.

The study will be performed in 4 parts, Parts 1 to 4. In Parts 1, 3 and 4,
single doses of MT-4129 will be administered whereas in Part 2, multiple doses
of MT-4129 will be administered. The purpose of the study is to investigate how
safe MT-4129 is and how well MT-4129 is tolerated.
It will also be investigated how quickly and to what extent MT-4129 is absorbed
by and eliminated from the body (this is called pharmacokinetics). Further, the
effect of the compound on certain proteins in your blood will be investigated
(this is called pharmacodynamics). In addition, the effect
of gender (Part 3) and age (Part 4) on MT-4129 pharmacokinetics and
pharmacodynamics will be investigated. This study will be performed in a
maximum of 136 healthy volunteers.

Part 1
Part 1 will be performed in a maximum of 9 dose groups each consisting of 8
healthy male Caucasian volunteers aged 18 to 55 years. Volunteers will
participate in 1 of these 9 dose groups.There will be 1 treatment period for
each volunteer. Part 1 will be performed in a maximum of
72 healthy male volunteers.

Part 2
Part 2 will be performed in a maximum of 4 dose groups each consisting of 12
healthy male volunteers. Volunteers will participate in 1 of these 4 dose
groups. There will be 1 treatment period for each volunteer. Part 2 will be
performed in a maximum of 48 healthy male volunteers.

Part 3 (gender effect)
Part 3 will be performed in 1 dose group consisting of 8 healthy female
Caucasian volunteers aged 18 to 55 years. There will be 1 treatment period for
each volunteer.

Part 4 (age effect)
Part 4 will be performed in 1 dose group consisting of 8 healthy male Caucasian
volunteers aged 65 years or higher. There will be 1 treatment period for each
volunteer.

First group day 1; 5 milligrams (mg) MT-4129 or placebo sober 1 capsul once
Second group day 1; 10 mg MT-4129 or placebo sober 1 capsul once
Third group day 1: 20 mg MT-4129 or placebo sober 1 capsul once
Fourth group day 1; 50 mg MT-4129 or placebo sober 1 capsul once
Fifth group day 1: 100 mg MT-4129 or placebo sober 1 capsul once
Sixth group day 1; 200 mg MT-4129 or placebo sober 2 capsules once
Seventh group day 1; 400 mg MT-4129 or placebo sober 4 capsules once
Eighth group day 1; 800 mg MT-4129 or placebo sober 8 capsules once
Nineth group day 1; TBD mg MT-4129 or placebo sober TBD capsules once

Part 2: The volunteers will receive either MT-4129 or placebo once daily for 7
days (from Day 1 to Day 7). This period may be prolonged to a maximum of 14
days. MT-4129 and placebo will be given in the form of oral capsules.

Infection, pain, minor bleedings, bruises and possibly an infection.