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ONO-7746 Study in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00956371
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE August 10, 2009
First Posted Date  ICMJE August 11, 2009
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
Safety and tolerability of ONO-7746 across ascending single doses [ Time Frame: study duration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
Characterization of PK and PD profiles of ONO-7746 [ Time Frame: study duration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ONO-7746 Study in Healthy Adult Subjects
Official Title  ICMJE A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects
Brief Summary The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Adult Subjects
Intervention  ICMJE Drug: ONO-7746
5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day
Study Arms  ICMJE
  • Placebo Comparator: P
    Intervention: Drug: ONO-7746
  • Experimental: E
    Intervention: Drug: ONO-7746
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2010)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2009)
72
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy non-smoking male or female subjects (18-55 years inclusive)
  • Body mass index (BMI) of 19-35 kg/m² (inclusive)
  • For females: postmenopausal, non-lactating and non-pregnant

Exclusion Criteria:

  • History or presence of clinically significant disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00956371
Other Study ID Numbers  ICMJE ONO-7746POU001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP