Study Evaluating Single Ascending Doses of MR1817

• Sponsor: Mochida Pharmaceutical Company, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00960180
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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 ascending single oral doses to healthy adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Adult	Drug: MR1817; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MR1817
Placebo Comparator: 2	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests [6 weeks]

Secondary Outcome Measures

1. MR1817 plasma and urine concentration. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cambridge		United Kingdom	CB23 2TN

Sponsors and Collaborators

• Mochida Pharmaceutical Company, Ltd.

Investigators

• Study Director: Robert Miller, Fulcrum Pharma (Europe) Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mochida Pharmaceutical Company, Ltd.
• ClinicalTrials.gov Identifier: NCT00960180
• Other Study ID Numbers: 3260A1-1000
• First Posted: Aug 17, 2009
• Last Update Posted: Jan 13, 2014
• Last Verified: May 1, 2011

Study Results

No Results Posted as of Jan 13, 2014