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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MT-7117; Drug: Placebo

• Registration Number: NCT02834442
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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, renal, cardiovascular or skin 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-7117 or Placebo	MT-7117	-
Single ascending dose, MT-7117 or Placebo	Placebo	-
Multiple ascending dose, MT-7117 or Placebo	MT-7117	-
Multiple ascending dose, MT-7117 or Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational center; 🇬🇧 United Kingdom, United Kingdom