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

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ClinicalTrials.gov Identifier: NCT01489345
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: ONO-2952 Drug: ONO-2952 Matching Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2011
Primary Completion Date : April 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events [ Time Frame: 36 days ]

Secondary Outcome Measures :
  1. Characterization of PK of ONO-2952 in plasma samples [ Time Frame: 36 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01489345     History of Changes
Other Study ID Numbers: ONO-2952POU002
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

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