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Completed

NCT Number: NCT02675309

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

The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational center

City Name, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-8554

Drug

Rosuvastatin

Drug

simvastatin

Drug

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.

    Time frame: 72 hours post dose

  2. Cmax of rosuvastatin alone and in the presence of MT-8554.

    Time frame: 72 hours post dose

  3. AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.

    Time frame: 24 hours post dose

  4. Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.

    Time frame: 24 hours post dose

Secondary outcomes

  1. Safety and Tolerability as measured by vital signs

    Time frame: Up to Day 16

  2. Safety and Tolerability as measured by number of participants with adverse events

    Time frame: Up to Day 16

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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