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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
History of Changes
  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
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 May 16, 2013