Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

June 12, 2012 updated by: Ono Pharma USA Inc

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miramar, Florida, United States, 33025
        • Miramar Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Placebo
Drug: ONO-6950
30 mg, 100 mg, 300 mg at multiple doses
Drug: ONO-6950
Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950
Experimental: E
ONO-6950
Drug: ONO-6950
30 mg, 100 mg, 300 mg at multiple doses
Drug: ONO-6950
Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At protocol-specified timepoints before and after study drug administration up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At protocol-specified timepoints before and after study drug administration up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ONO-6950POU002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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