A randomised, doubleblind, placebocontrolled, firsttimein*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.

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 SAD and MAD study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43193

Enrollment

136

Registered

2016-10-25

Start date

2016-11-29

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hoge bloeddruk, hartfalen en nierziekten. heartfailure and renal disorders. hypertension

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Parts 1 and 4: healthy male/ Part 3: healthy female Parts 1 and 3: 18 - 55 years, inclusive/Part 4: 65 years of age or older Parts 1, 3 and 4: Caucasian (person belonging to or originate from one of the original people of Europe, the Middle East, North Africa, or the Indian subcontinent) Parts 1 and 4: 60 kilograms or higher/Part 3: 50 kilograms or higher BMI 18.0 - 30.0 kilograms/meter2 non smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.	—

Secondary

Measure	Time frame
To investigate the pharmacokinetic (PK) profile of MT-4129 after single and multiple ascending oral doses in healthy subjects To investigate the pharmacodynamic (PD) parameters (e.g., plasma aldosterone and serum cortisol concentration) after single and multiple oral doses of MT-4129 in healthy subjects To evaluate the effect of gender and age on the PK and PD of MT-4129 after administration of single oral doses in healthy subjects	—

Measure

Time frame

To investigate the pharmacokinetic (PK) profile of MT-4129 after single and multiple ascending oral doses in healthy subjects To investigate the pharmacodynamic (PD) parameters (e.g., plasma aldosterone and serum cortisol concentration) after single and multiple oral doses of MT-4129 in healthy subjects To evaluate the effect of gender and age on the PK and PD of MT-4129 after administration of single oral doses in healthy subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)