A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects

December 16, 2025 updated by: Tanabe Pharma Corporation
The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy and free from clinically significant illness or disease
  • Male Caucasian subjects aged 18 to 55
  • A body weight of ≥60 kg

Exclusion Criteria:

  • Participation in more than three clinical studies involving administration of an Investigational Medicinal Product 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-8554, rosuvastatin and simvastatin
Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively.
Drug: rosuvastatin
Drug: simvastatin
Drug: MT-8554

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.
Time Frame: 72 hours post dose
72 hours post dose
Cmax of rosuvastatin alone and in the presence of MT-8554.
Time Frame: 72 hours post dose
72 hours post dose
AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.
Time Frame: 24 hours post dose
24 hours post dose
Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.
Time Frame: 24 hours post dose
24 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as measured by vital signs
Time Frame: Up to Day 16
Up to Day 16
Safety and Tolerability as measured by number of participants with adverse events
Time Frame: Up to Day 16
Up to Day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimated)

February 5, 2016

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-8554-E05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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