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

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.

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: ONO-7746 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : November 2010

Arm Intervention/treatment
Placebo Comparator: P Drug: ONO-7746
1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.

Experimental: E Drug: ONO-7746
1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Characterization of PK and PD profiles, including platelet count changes of ONO-7746 [ Time Frame: up to 42 days ]
  2. Effect of food on ONO-7746 pharmacokinetics [ Time Frame: up to 42 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106664

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United States, Texas
Austin Clinical Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
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Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
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Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT01106664    
Other Study ID Numbers: ONO-7746POU002
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Keywords provided by Ono Pharmaceutical Co. Ltd:
Healthy adult subjects