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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834442
• Other study ID #: MT-7117-E01
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2016
• Last updated: July 24, 2017
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: July 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, tolerability and pharmacokinetics of MT-7117 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 2017
• Est. primary completion date: June 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, renal, cardiovascular or skin 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-7117

• Placebo

Locations

Country	Name	City	State
United Kingdom	Investigational center	United Kingdom

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as measured by number of participants with adverse events		up to Day56
Primary	Safety and Tolerability as measured by vital signs		up to Day56
Primary	Safety and Tolerability as measured by physical examination		up to Day56
Primary	Safety and Tolerability as measured by ECG		up to Day21
Primary	Safety and Tolerability as measured by laboratory safety assessments		up to Day21
Secondary	Maximum plasma concentration (Cmax)		96 hours post dose
Secondary	Area under the plasma concentration-time curve (AUC)		96 hours post dose
Secondary	Time to maximum plasma concentration (Tmax)		96 hours post dose
Secondary	Apparent elimination half-life in plasma		96 hours post dose