- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379586
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd
A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food on This Profile in Healthy Male and Female Subjects
The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects.
The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is a first-in-human study of ONO-4053 in healthy volunteers.
This study consists of three parts.
Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner.
Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner.
Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner.
Doses for Part B and C will be determined after data from Part A are available.
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9LH
- Leeds Clinical Site
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy caucasian subjects aged 18-45 years inclusive
- Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.
Exclusion Criteria:
- Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
- Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: P
Placebo
|
Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053
|
Experimental: E
ONO-4053
|
Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.
Time Frame: At protocol-specified timepoints before and after study drug administration up to Day 14
|
At protocol-specified timepoints before and after study drug administration up to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters
Time Frame: At protocol-specified timepoints before and after study drug administration up to Day 14
|
At protocol-specified timepoints before and after study drug administration up to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Department, Ono Pharmaceutical Co. 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
June 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 21, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- ONO-4053POE001
- Eudra CT No. 2010-023049-31
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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