Healthy
Conditions
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.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554. | 72 hours post dose |
| Cmax of rosuvastatin alone and in the presence of MT-8554. | 72 hours post dose |
| AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554. | 24 hours post dose |
| Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554. | 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as measured by number of participants with adverse events | Up to Day 16 |
| Safety and Tolerability as measured by vital signs | Up to Day 16 |
Countries
United Kingdom
Outcome results
None listed