Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
NCT ID: NCT01508988
Last Updated: 2012-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Eye drops 0.3 µg/mL
ONO-9054
Eye drops 0.3 µg/mL both eyes on Day one
Eye drops 1 µg/mL
ONO-9054
Eye drops 1 µg/mL both eyes on Day one
Eye drops 3 µg/mL
ONO-9054
Eye drops 3 µg/mL both eyes on Day one
Eye drops 10 µg/mL
ONO-9054
Eye drops 10 µg/mL both eyes on Day one
Eye drops 20 µg/mL
ONO-9054
Eye drops 20 µg/mL both eyes on Day one
Eye drops 30 µg/mL
ONO-9054
Eye drops 30 µg/mL both eyes on Day one
Eye drops placebo
ONO-9054
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Interventions
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ONO-9054
Eye drops 0.3 µg/mL both eyes on Day one
ONO-9054
Eye drops 1 µg/mL both eyes on Day one
ONO-9054
Eye drops 3 µg/mL both eyes on Day one
ONO-9054
Eye drops 10 µg/mL both eyes on Day one
ONO-9054
Eye drops 20 µg/mL both eyes on Day one
ONO-9054
Eye drops 30 µg/mL both eyes on Day one
ONO-9054
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
64 Years
ALL
Yes
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Ono Pharma USA, Inc.
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Covance Phase 1 Unit
Dallas, Texas, United States
Countries
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References
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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.
Other Identifiers
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ONO-9054IOU001
Identifier Type: -
Identifier Source: org_study_id
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