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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