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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rosuvastatin; Drug: simvastatin; Drug: MT-8554

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675309

MT-8554-E05

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

MT-8554, rosuvastatin and simvastatin

Experimental group

Description:

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.

Treatment:

Drug: MT-8554

Drug: simvastatin

Drug: rosuvastatin