A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects | NCT02675309 | Trialant
CompletedInterventionalPhase 1Updated Dec 22, 2025
A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects
ClinicalTrials.gov ID
NCT02675309
Lead Sponsor
Tanabe Pharma CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
28Actual
Last Update Posted
Dec 22, 2025Actual
Start Date
Feb 2016
Primary Completion Date
Mar 2016Actual
Completion Date
Mar 2016Actual
Brief Summary
The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.
Healthy
MT-8554
rosuvastatin
simvastatin
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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