NCT01106664
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ONO-7746
- Conditions
- Healthy Adult Subjects
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Safety Assessment
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy non-smoking male or female subjects (18-55 inclusive)
- •Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- •For females, postmenopausal, non-lactating, and non-pregnant
Exclusion Criteria
- •History or presence of clinically significant disease
Arms & Interventions
P
Intervention: ONO-7746
E
Intervention: ONO-7746
Outcomes
Primary Outcomes
Safety Assessment
Time Frame: up to 42 days
(evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)
Secondary Outcomes
- Effect of food on ONO-7746 pharmacokinetics(up to 42 days)
- Characterization of PK and PD profiles, including platelet count changes of ONO-7746(up to 42 days)
Study Sites (1)
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