NCT01297582

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

February 11, 2011

Last Update Submit

June 12, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-6950Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

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

    up to 7 days

Secondary Outcomes (2)

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

    up to 7 days

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

    up to 15 days

Study Arms (2)

E

EXPERIMENTAL
Drug: ONO-6950

P

PLACEBO COMPARATOR
Drug: ONO-6950

Interventions

ONO-6950DRUG

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

E

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History or presence of clinical significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miramar Clinical Site

Miramar, Florida, 33025, United States

Location

MeSH Terms

Interventions

gemilukast

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 17, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)