NCT01508988

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

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, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3 months

First QC Date

January 9, 2012

Last Update Submit

June 12, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-9054adult healthy volunteerssingle dosephase 1

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events

    up to 4 days

Secondary Outcomes (2)

  • 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample

    up to 2 days

  • 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering

    up to 2 days

Study Arms (7)

Eye drops 0.3 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops 1 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops 3 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops 10 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops 20 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops 30 µg/mL

EXPERIMENTAL
Drug: ONO-9054

Eye drops placebo

EXPERIMENTAL
Drug: ONO-9054

Interventions

ONO-9054DRUG

Eye drops 0.3 µg/mL both eyes on Day one

Eye drops 0.3 µg/mL

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female subjects, aged 18-64 inclusive
  • Body mass index (BMI) of 19-35 kg/m2 (inclusive)
  • IOP measurement oculus uterque (OU, both eyes) \< 21 mm Hg (inclusive) at screening and Day -1
  • Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1

You may not qualify if:

  • Any history of severe ocular trauma in either eye at any time
  • Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye
  • Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye
  • At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results
  • Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of the study
  • History of clinically significant drug or food allergy, positive HIV, hepatitis B or C at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Phase 1 Unit

Dallas, Texas, 75247, United States

Location

Related Publications (1)

  • Suto F, Rowe-Rendleman CL, Ouchi T, Jamil A, Wood A, Ward CL. A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7963-70. doi: 10.1167/iovs.15-18166.

    PMID: 26720443DERIVED

MeSH Terms

Interventions

propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate

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

January 9, 2012

First Posted

January 12, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)