Study Evaluating Single Ascending Doses of MR1817

Adult Clinical Trial

Official title:

A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960180
• Other study ID #: 3260A1-1000
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: January 9, 2014
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult

Intervention

Drug:
• MR1817

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests		6 weeks	Yes
Secondary	MR1817 plasma and urine concentration.		6 weeks	No