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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MT-8554; Drug: rosuvastatin; Drug: simvastatin

• Registration Number: NCT02675309
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-05
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-8554, rosuvastatin and simvastatin	MT-8554	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.
MT-8554, rosuvastatin and simvastatin	rosuvastatin	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.
MT-8554, rosuvastatin and simvastatin	simvastatin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by vital signs	Up to Day 16
Safety and Tolerability as measured by number of participants with adverse events	Up to Day 16

Trial Locations

Locations (1)

Investigational center; 🇬🇧 City name, United Kingdom