Clinical trial NCT02953132: A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Safety and Tolerability as measured by incidence and severity of adverse events
timeFrame: Up to Day 14
measure: Safety and Tolerability as measured by vital signs
timeFrame: Up to Day 14
measure: Safety and Tolerability as measured by ECG
timeFrame: Up to Day 14
measure: Safety and Tolerability as measured by clinical laboratory assessments
timeFrame: Up to Day 14
measure: Safety and Tolerability as measured by Hormone assessments
timeFrame: Up to Day 10
measure: Safety and Tolerability as measured by physical examination
timeFrame: Up to Day 14
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of MT-4129
timeFrame: Up to Day 10
measure: Measured time of maximum observed plasma concentration (tmax) of MT-4129
timeFrame: Up to Day 10
measure: Apparent terminal elimination half-life (t1/2) of MT-4129
timeFrame: Up to Day 10
measure: AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129
timeFrame: Up to Day 8
measure: AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129
timeFrame: Up to Day 9
measure: AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129
timeFrame: Up to Day 10
measure: AUC from time zero to infinity (AUC0-∞) of MT-4129
timeFrame: Up to Day 10
measure: AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129
timeFrame: Up to Day 10
measure: AUC over the dosing interval (AUC0-t) of MT-4129
timeFrame: Up to Day 10
measure: Terminal elimination rate constant (Kel) of MT-4129
timeFrame: Up to Day 10
measure: Mean residence time (MRT) of MT-4129
timeFrame: Up to Day 10
measure: Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129
timeFrame: Up to Day 10
measure: Apparent volume of distribution at steady state (Vss/F) of MT-4129
timeFrame: Up to Day 10
measure: Apparent oral clearance (CL/F) of MT-4129
timeFrame: Up to Day 10
measure: Urinary excreted amount of test compound (Ae) of MT-4129
timeFrame: Up to Day 10
measure: Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129
timeFrame: Up to Day 10
measure: Renal clearance (CLR) of MT-4129
timeFrame: Up to Day 10
measure: Plasma aldosterone
timeFrame: Up to Day 10
measure: Serum cortisol
timeFrame: Up to Day 10
measure: Plasma steroid hormones
timeFrame: Up to Day 10
measure: Urinary aldosterone
timeFrame: Up to Day 10
measure: Urinary cortisol
timeFrame: Up to Day 10
measure: Urinary sodium
timeFrame: Up to Day 10
measure: Urine potassium
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: City Name
country: Netherlands
facility: Pharmaceutical Research Associates (PRA) Health Sciences
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: