ONO-7746 Study in Healthy Adult Subject

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

Tracking Information

• First Submitted Date: April 13, 2010
• First Posted Date: April 20, 2010
• Last Update Posted Date: June 14, 2012
• Study Start Date: April 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ONO-7746 Study in Healthy Adult Subject
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Healthy Adult Subjects

Intervention

• 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

• Placebo Comparator: P
  Intervention: Drug: ONO-7746
• Experimental: E
  Intervention: Drug: ONO-7746

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2010): 72
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01106664
• Other Study ID Numbers: ONO-7746POU002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ono Pharmaceutical Co. Ltd
• Study Sponsor: Ono Pharmaceutical Co. Ltd
• Collaborators: Not Provided

Investigators

• Study Director: Ono Pharma USA, Inc.; Ono Pharmaceutical Co. Ltd

• PRS Account: Ono Pharmaceutical Co. Ltd
• Verification Date: June 2012