Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
- Registration Number
- NCT01297582
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI) of 19-35kg/m2 (inclusive)
- For females, postmenopausal, non-lactating, and non-pregnant
Exclusion Criteria
- History or presence of clinical significant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P ONO-6950 - E ONO-6950 -
- Primary Outcome Measures
Name Time Method Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations up to 7 days
- Secondary Outcome Measures
Name Time Method Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects up to 7 days Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions up to 15 days
Trial Locations
- Locations (1)
Miramar Clinical Site
🇺🇸Miramar, Florida, United States