Clinical trial NCT01508988: Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
Official title: A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-9054
adult healthy volunteers
single dose
phase 1
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
timeFrame: up to 4 days
Secondary outcomes:
measure: 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample
timeFrame: up to 2 days
measure: 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering
timeFrame: up to 2 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Phase 1 Unit
state: Texas
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
citation: 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.