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CompletedNCT01297582Updated Jun 14, 2012

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

A Phase 1 interventional study of ONO-6950 and ONO-6950 in Healthy Adult Subjects, sponsored by Ono Pharma USA Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by Ono Pharma USA Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Adult Subjects

Keywords

  • ONO-6950
  • Healthy Adult Subjects
03

In context

Lead sponsor

Ono Pharma USA Inc is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • History or presence of clinical significant disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    E

    Drug: ONO-6950

  • Placebo comparator
    P

    Drug: ONO-6950

Interventions

  • DrugONO-6950

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

  • DrugONO-6950

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

06

What researchers measure

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

07

Study locations

1 site
  • Miramar Clinical Site
    Miramar, Florida 33025, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01297582
Lead sponsor
Ono Pharma USA Inc
Responsible party
Sponsor
First posted
Feb 17, 2011
Start date
Jan 2011
Primary completion
Jun 2011
Last update
Jun 14, 2012

Study contacts

Ono Pharma USA, Inc.
study director · Ono Pharmaceutical Co. Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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