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Completed

NCT Number: NCT01297582

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.

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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

Miramar Clinical Site

Miramar, Florida, 33025, 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 19-35kg/m2 (inclusive)
  • For females, postmenopausal, non-lactating, and non-pregnant

Exclusion criteria

  • History or presence of clinical significant disease

Treatment and study plan

ONO-6950

Drug

1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study

Primary outcomes

  1. Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations

    Time frame: up to 7 days

Secondary outcomes

  1. Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects

    Time frame: up to 7 days

  2. Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions

    Time frame: up to 15 days

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 17, 2011
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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