A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02834442

Collaborator

(none)

144

Enrollment

Location

Arms

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: MT-7117 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single ascending dose, MT-7117 or Placebo	Drug: MT-7117 Drug: Placebo
Experimental: Multiple ascending dose, MT-7117 or Placebo	Drug: MT-7117 Drug: Placebo

Arm

Intervention/Treatment

Experimental: Single ascending dose, MT-7117 or Placebo

Drug: MT-7117

Drug: Placebo

Experimental: Multiple ascending dose, MT-7117 or Placebo

Drug: MT-7117

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Safety and Tolerability as measured by number of participants with adverse events [up to Day56]
Safety and Tolerability as measured by vital signs [up to Day56]
Safety and Tolerability as measured by physical examination [up to Day56]
Safety and Tolerability as measured by ECG [up to Day21]
Safety and Tolerability as measured by laboratory safety assessments [up to Day21]

Secondary Outcome Measures

Maximum plasma concentration (Cmax) [96 hours post dose]
Area under the plasma concentration-time curve (AUC) [96 hours post dose]
Time to maximum plasma concentration (Tmax) [96 hours post dose]
Apparent elimination half-life in plasma [96 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
Clinically relevant abnormal medical history, physical findings or laboratory values

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational center	United Kingdom		United Kingdom

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT02834442

Other Study ID Numbers:

MT-7117-E01

First Posted:

Jul 15, 2016

Last Update Posted:

Jul 25, 2017

Last Verified:

Jul 1, 2017

Study Results

No Results Posted as of Jul 25, 2017