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

May 25, 2011
June 12, 2012
May 2011
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01364441 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Adult Subjects
  • Drug: ONO-2952
    3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study
  • Drug: Placebo
    Placebo dosed in the same manner as ONO-2952
  • Placebo Comparator: P
    Intervention: Drug: Placebo
  • Experimental: E
    Intervention: Drug: ONO-2952
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01364441
ONO-2952POU001
No
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Ono Pharma USA Inc
Not Provided
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP