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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429102
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : April 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Single ascending dose, MT-8554 or Placebo Drug: MT-8554
Drug: Placebo
Experimental: Multiple ascending dose, MT-8554 or Placebo Drug: MT-8554
Drug: Placebo



Primary Outcome Measures :
  1. Safety and Tolerability as measured by vital signs [ Time Frame: up to Day14 ]
  2. Safety and Tolerability as measured by ECG [ Time Frame: up to Day14 ]
  3. Safety and Tolerability as measured by continuous lead II ECG monitoring [ Time Frame: up to Day14 ]
  4. Safety and Tolerability as measured by laboratory safety assessments [ Time Frame: up to Day14 ]
  5. Safety and Tolerability as measured by physical examination [ Time Frame: up to Day14 ]
  6. Safety and Tolerability as measured by number of participants with adverse events [ Time Frame: up to Day14 ]

Secondary Outcome Measures :
  1. PK profile (Cmax, tmax, t½, AUC) [ Time Frame: 240 hours post dose ]
    Cmax, tmax, t½, AUC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy and free from clinically significant illness or disease
  • Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
  • A body weight of ≥60 kg male and ≥50 kg female

Exclusion Criteria:

  • Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) 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): NCT02429102


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: NCT02429102    
Other Study ID Numbers: MT-8554-E01
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Phase 1
Healthy subjects
Pharmacokinetics of MT-8554