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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. Identifier: NCT00956371
Recruitment Status : Completed
First Posted : August 11, 2009
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 ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

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 : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects
Study Start Date : August 2009
Actual Primary Completion Date : March 2010

Arm Intervention/treatment
Placebo Comparator: P Drug: ONO-7746
5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day

Experimental: E Drug: ONO-7746
5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day

Primary Outcome Measures :
  1. Safety and tolerability of ONO-7746 across ascending single doses [ Time Frame: study duration ]

Secondary Outcome Measures :
  1. Characterization of PK and PD profiles of ONO-7746 [ Time Frame: study duration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 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

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): NCT00956371

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United States, Texas
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: NCT00956371    
Other Study ID Numbers: ONO-7746POU001
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012
Keywords provided by Ono Pharmaceutical Co. Ltd:
Healthy adult subjects