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Completed

NCT Number: NCT00956371

ONO-7746 Study in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

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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

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 years 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

5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day

Primary outcomes

  1. Safety and tolerability of ONO-7746 across ascending single doses

    Time frame: study duration

Secondary outcomes

  1. Characterization of PK and PD profiles of ONO-7746

    Time frame: study duration

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects

Important dates

Study start
2009
Primary completion
2010
First posted
Aug 11, 2009
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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