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Completed

NCT Number: NCT01106664

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin Clinical Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-7746

Drug

1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.

Primary outcomes

  1. 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

  1. Characterization of PK and PD profiles, including platelet count changes of ONO-7746

    Time frame: up to 42 days

  2. Effect of food on ONO-7746 pharmacokinetics

    Time frame: up to 42 days

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
First posted
Apr 20, 2010
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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