Status:
COMPLETED
Study Evaluating Single Ascending Doses of MR1817
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Conditions:
Adult
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ...
Eligibility Criteria
Inclusion
- Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening.
- 2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.
- Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00960180
Start Date
July 1 2010
End Date
January 1 2011
Last Update
January 13 2014
Active Locations (1)
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1
Cambridge, United Kingdom, CB23 2TN