NCT01106664CompletedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Safety Assessment
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Placebo Comparator
Intervention: ONO-7746 (Drug)
E
Experimental
Intervention: ONO-7746 (Drug)
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)
Investigators
Study Sites (1)
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