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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953132
• Other study ID #: MT-4129-E01
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2016
• Last updated: May 16, 2017
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-4129

• Placebo

Locations

Country	Name	City	State
Netherlands	Pharmaceutical Research Associates (PRA) Health Sciences	City Name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as measured by incidence and severity of adverse events		Up to Day 14
Primary	Safety and Tolerability as measured by vital signs		Up to Day 14
Primary	Safety and Tolerability as measured by ECG		Up to Day 14
Primary	Safety and Tolerability as measured by clinical laboratory assessments		Up to Day 14
Primary	Safety and Tolerability as measured by Hormone assessments		Up to Day 10
Primary	Safety and Tolerability as measured by physical examination		Up to Day 14
Secondary	Maximum observed plasma concentration (Cmax) of MT-4129		Up to Day 10
Secondary	Measured time of maximum observed plasma concentration (tmax) of MT-4129		Up to Day 10
Secondary	Apparent terminal elimination half-life (t1/2) of MT-4129		Up to Day 10
Secondary	AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129		Up to Day 8
Secondary	AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129		Up to Day 9
Secondary	AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129		Up to Day 10
Secondary	AUC from time zero to infinity (AUC0-8) of MT-4129		Up to Day 10
Secondary	AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129		Up to Day 10
Secondary	AUC over the dosing interval (AUC0-t) of MT-4129		Up to Day 10
Secondary	Terminal elimination rate constant (Kel) of MT-4129		Up to Day 10
Secondary	Mean residence time (MRT) of MT-4129		Up to Day 10
Secondary	Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129		Up to Day 10
Secondary	Apparent volume of distribution at steady state (Vss/F) of MT-4129		Up to Day 10
Secondary	Apparent oral clearance (CL/F) of MT-4129		Up to Day 10
Secondary	Urinary excreted amount of test compound (Ae) of MT-4129		Up to Day 10
Secondary	Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129		Up to Day 10
Secondary	Renal clearance (CLR) of MT-4129		Up to Day 10
Secondary	Plasma aldosterone		Up to Day 10
Secondary	Serum cortisol		Up to Day 10
Secondary	Plasma steroid hormones		Up to Day 10
Secondary	Urinary aldosterone		Up to Day 10
Secondary	Urinary cortisol		Up to Day 10
Secondary	Urinary sodium		Up to Day 10
Secondary	Urine potassium		Up to Day 10