Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ONO-7746 Study in Healthy Adult Subject

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: April 13, 2010
Last updated: June 12, 2012
Last verified: June 2012
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 Intervention Phase
Healthy Adult Subjects
Drug: ONO-7746
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 72
Study Start Date: April 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01106664

United States, Texas
Austin Clinical Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT01106664     History of Changes
Other Study ID Numbers: ONO-7746POU002
Study First Received: April 13, 2010
Last Updated: June 12, 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
Healthy adult subjects processed this record on May 25, 2017