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

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ClinicalTrials.gov Identifier: NCT01364441
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: ONO-2952 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Study Start Date : May 2011
Actual Primary Completion Date : August 2011

Arm Intervention/treatment
Placebo Comparator: P Drug: Placebo
Placebo dosed in the same manner as ONO-2952

Experimental: E Drug: ONO-2952
3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study




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: up to 8 days ]

Secondary Outcome Measures :
  1. Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample [ Time Frame: up to 8 days ]
  2. Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions [ Time Frame: up to 24 days ]


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

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): NCT01364441


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01364441     History of Changes
Other Study ID Numbers: ONO-2952POU001
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-2950
healthy adult subjects
first in human
safety
tolerability
pharmacokinetics