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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MT-4129; Drug: Placebo

• Registration Number: NCT02953132
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study Start: 2016-11
• Study First Posted: 2016-11-02
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single ascending dose, MT-4129 or Placebo	Placebo	-
Multiple ascending dose, MT-4129 or Placebo	Placebo	-
Multiple ascending dose, MT-4129 or Placebo	MT-4129	-
Single ascending dose, MT-4129 or Placebo	MT-4129	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pharmaceutical Research Associates (PRA) Health Sciences; 🇳🇱 City Name, Netherlands