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Completed

NCT Number: NCT01405651

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 multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.

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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 10-35 kg/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

30 mg, 100 mg, 300 mg at multiple doses

Primary outcomes

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

    Time frame: At protocol-specified timepoints before and after study drug administration up to 21 days

Secondary outcomes

  1. Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests

    Time frame: At protocol-specified timepoints before and after study drug administration up to 21 days

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose 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
Jul 29, 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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