A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MT-8554; Drug: Placebo

• Registration Number: NCT02429102
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 male and ≥50 kg female

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Exclusion Criteria

• Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
• Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, 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
Multiple ascending dose, MT-8554 or Placebo	Placebo	-
Single ascending dose, MT-8554 or Placebo	MT-8554	-
Single ascending dose, MT-8554 or Placebo	Placebo	-
Multiple ascending dose, MT-8554 or Placebo	MT-8554	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by vital signs	up to Day14
Safety and Tolerability as measured by ECG	up to Day14
Safety and Tolerability as measured by continuous lead II ECG monitoring	up to Day14
Safety and Tolerability as measured by laboratory safety assessments	up to Day14
Safety and Tolerability as measured by number of participants with adverse events	up to Day14
Safety and Tolerability as measured by physical examination	up to Day14

Secondary Outcome Measures

Name	Time	Method
PK profile (Cmax, tmax, t½, AUC)	240 hours post dose	Cmax, tmax, t½, AUC

Trial Locations

Locations (1)

Investigational center; 🇬🇧 City name, United Kingdom