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ONO-7746 Study in Healthy Adult Subject

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: NCT01106664
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE April 13, 2010
First Posted Date  ICMJE April 20, 2010
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Safety Assessment [ Time Frame: up to 42 days ]
(evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01106664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • Characterization of PK and PD profiles, including platelet count changes of ONO-7746 [ Time Frame: up to 42 days ]
  • Effect of food on ONO-7746 pharmacokinetics [ Time Frame: up to 42 days ]
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 Subject
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study and Food Effect 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 NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.
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
    1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
  • Drug: ONO-7746
    1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study
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: April 19, 2010)
72
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy non-smoking male or female subjects (18-55 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 NCT01106664
Other Study ID Numbers  ICMJE ONO-7746POU002
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