NCT01405651

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 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

July 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3 months

First QC Date

July 22, 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 and physical examinations

    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

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

Study Arms (2)

E

EXPERIMENTAL

ONO-6950

Drug: ONO-6950

P

PLACEBO COMPARATOR

Placebo

Drug: ONO-6950

Interventions

ONO-6950DRUG

30 mg, 100 mg, 300 mg at multiple doses

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 10-35 kg/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

July 22, 2011

First Posted

July 29, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)