ONO-7746 Study in Healthy Adult Subject
The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects|
- Safety Assessment [ Time Frame: up to 42 days ] [ Designated as safety issue: Yes ](evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)
- Characterization of PK and PD profiles, including platelet count changes of ONO-7746 [ Time Frame: up to 42 days ] [ Designated as safety issue: Yes ]
- Effect of food on ONO-7746 pharmacokinetics [ Time Frame: up to 42 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: P||
1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study