Single-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:
NCT01364441
First received: May 25, 2011
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-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 Intervention Phase
Healthy Adult Subjects
Drug: ONO-2952
Drug: Placebo
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 and Food Effect 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: up to 8 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions [ Time Frame: up to 24 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: May 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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: 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
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01364441     History of Changes
Other Study ID Numbers: ONO-2952POU001
Study First Received: May 25, 2011
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014