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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Rosuvastatin Calcium; Simvastatin

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