Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
- Registration Number
- NCT01364441
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P Placebo - E ONO-2952 -
- Primary Outcome Measures
Name Time Method Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events up to 8 days
- Secondary Outcome Measures
Name Time Method Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample up to 8 days Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions up to 24 days
Trial Locations
- Locations (1)
Austin Clinical Site
🇺🇸Austin, Texas, United States