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

December 7, 2011
July 31, 2012
December 2011
April 2012   (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: 36 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01489345 on ClinicalTrials.gov Archive Site
Characterization of PK of ONO-2952 in plasma samples [ Time Frame: 36 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
A Double-Blind, Placebo-Controlled, Multiple Dose Escalation 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 multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: ONO-2952
    30 mg to 100 mg QD at a multiple dose, and 21 days duration
  • Drug: ONO-2952 Matching Placebo
    30 mg to 100 mg QD at a multiple dose, and 21 days duration
  • Experimental: Arm 1: Experimental
    Intervention: Drug: ONO-2952
  • Placebo Comparator: Arm 2: Placebo Comparator
    Intervention: Drug: ONO-2952 Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
April 2012   (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
 
NCT01489345
ONO-2952POU002
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
July 2012

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