Study Evaluating Single Ascending Doses of MR1817

January 9, 2014 updated by: Mochida Pharmaceutical Company, Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
MR1817 plasma and urine concentration.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mochida Pharmaceutical Company, Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

May 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 3260A1-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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