ONO-7746 Study in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00956371
First received: August 10, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Healthy Adult Subjects
Drug: ONO-7746
Phase 1

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

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

Primary Outcome Measures:
  • Safety and tolerability of ONO-7746 across ascending single doses [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of PK and PD profiles of ONO-7746 [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: August 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00956371

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00956371     History of Changes
Other Study ID Numbers: ONO-7746POU001
Study First Received: August 10, 2009
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-7746
Healthy adult subjects

ClinicalTrials.gov processed this record on September 22, 2014