ONO-7746 Study in Healthy Adult Subject
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: November 2010
Interventions
- Drug: ONO-7746
- 1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
- Drug: ONO-7746
- 1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study
Arms, Groups and Cohorts
- Placebo Comparator: P
- Experimental: E
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Characterization of PK and PD profiles, including platelet count changes of ONO-7746
- Time Frame: up to 42 days
- Effect of food on ONO-7746 pharmacokinetics
- Time Frame: up to 42 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ono Pharma USA, Inc., Study Director, Ono Pharmaceutical Co. Ltd
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