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

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ClinicalTrials.gov Identifier: NCT02675309
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MT-8554 Drug: rosuvastatin Drug: simvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MT-8554, rosuvastatin and 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.
Drug: MT-8554
Drug: rosuvastatin
Drug: simvastatin



Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554. [ Time Frame: 72 hours post dose ]
  2. Cmax of rosuvastatin alone and in the presence of MT-8554. [ Time Frame: 72 hours post dose ]
  3. AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554. [ Time Frame: 24 hours post dose ]
  4. Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554. [ Time Frame: 24 hours post dose ]

Secondary Outcome Measures :
  1. Safety and Tolerability as measured by vital signs [ Time Frame: Up to Day 16 ]
  2. Safety and Tolerability as measured by number of participants with adverse events [ Time Frame: Up to Day 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675309


Locations
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United Kingdom
Investigational center
City name, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02675309    
Other Study ID Numbers: MT-8554-E05
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors