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

NCT ID: NCT02429102

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 Healthy subjects Pharmacokinetics of MT-8554

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Study Groups

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Single ascending dose, MT-8554 or Placebo

Group Type EXPERIMENTAL

MT-8554

Intervention Type DRUG

Placebo

Intervention Type DRUG

Multiple ascending dose, MT-8554 or Placebo

Group Type EXPERIMENTAL

MT-8554

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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MT-8554

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational center

City Name, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MT-8554-E01

Identifier Type: -

Identifier Source: org_study_id