Study Evaluating Single Ascending Doses of MR1817

Phase 1

Completed

• Conditions: Adult
• Interventions: Drug: MR1817; Drug: Placebo

• Registration Number: NCT00960180
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-05
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MR1817	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests	6 weeks

Secondary Outcome Measures

Name	Time	Method
MR1817 plasma and urine concentration.	6 weeks