Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: ONO-9054; Drug: ONO-9054; Drug: ONO-9054; Drug: ONO-9054; Drug: ONO-9054; Drug: ONO-9054; Drug: ONO-9054

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Phase 1 Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye drops 0.3 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops 1 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops 3 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops 10 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops 20 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops 30 µg/mL	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Experimental: Eye drops placebo	Drug: ONO-9054; Eye drops 0.3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 1 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 3 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 10 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 20 µg/mL both eyes on Day one; Drug: ONO-9054; Eye drops 30 µg/mL both eyes on Day one; Drug: ONO-9054; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ono Pharma USA Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: phase 1; single dose; ONO-9054; adult healthy volunteers
• Other Study ID Numbers: ONO-9054IOU001