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Study Evaluating Single Ascending Doses of MR1817

This study has been completed.
Sponsor:
Information provided by:
Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier:
NCT00960180
First received: August 14, 2009
Last updated: May 23, 2011
Last verified: May 2011
History of Changes

August 14, 2009
May 23, 2011
July 2010
January 2011   (final data collection date for primary outcome measure)
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00960180 on ClinicalTrials.gov Archive Site
MR1817 plasma and urine concentration. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
VRA-175 plasma and urine concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating Single Ascending Doses of MR1817
A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects

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 ascending single oral doses to healthy adult subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Adult
  • Drug: MR1817
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: MR1817
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00960180
3260A1-1000
No
Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Company, Ltd.
Not Provided
Study Director: Robert Miller Fulcrum Pharma (Europe) Ltd
Mochida Pharmaceutical Company, Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP