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Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01489345
First received: December 7, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.


Condition Intervention Phase
Healthy
 Drug: ONO-2952
Drug: ONO-2952 Matching Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

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

Primary Outcome Measures:
  • Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of PK of ONO-2952 in plasma samples [ Time Frame: 36 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2011
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Experimental Drug: ONO-2952
30 mg to 100 mg QD at a multiple dose, and 21 days duration
Placebo Comparator: Arm 2: Placebo Comparator Drug: ONO-2952 Matching Placebo
30 mg to 100 mg QD at a multiple dose, and 21 days duration

  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 inclusive)
  • Body mass index (BMI) of 19-35 kg/m2 (inclusive)
  • For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

  • History or presence of clinically significant disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489345

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01489345     History of Changes
Other Study ID Numbers: ONO-2952POU002
Study First Received: December 7, 2011
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2952
Healthy adult subjects
Multiple dose
 Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on May 22, 2013