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Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01508988
First received: January 9, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Adult Subjects
 Drug: ONO-9054
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events [ Time Frame: up to 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]
  • 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eye drops 0.3 µg/mL Drug: ONO-9054
Eye drops 0.3 µg/mL both eyes on Day one
Experimental: Eye drops 1 µg/mL Drug: ONO-9054
Eye drops 1 µg/mL both eyes on Day one
Experimental: Eye drops 3 µg/mL Drug: ONO-9054
Eye drops 3 µg/mL both eyes on Day one
Experimental: Eye drops 10 µg/mL Drug: ONO-9054
Eye drops 10 µg/mL both eyes on Day one
Experimental: Eye drops 20 µg/mL Drug: ONO-9054
Eye drops 20 µg/mL both eyes on Day one
Experimental: Eye drops 30 µg/mL Drug: ONO-9054
Eye drops 30 µg/mL both eyes on Day one
Experimental: Eye drops placebo Drug: ONO-9054
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508988

Locations
United States, Texas
Covance Phase 1 Unit
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01508988     History of Changes
Other Study ID Numbers: ONO-9054IOU001
Study First Received: January 9, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-9054
adult healthy volunteers
single dose
phase 1

ClinicalTrials.gov processed this record on May 22, 2013