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

January 9, 2012
June 12, 2012
January 2012
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01508988 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Adult Subjects
  • 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 0.3 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops 1 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops 3 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops 10 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops 20 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops 30 µg/mL
    Intervention: Drug: ONO-9054
  • Experimental: Eye drops placebo
    Intervention: Drug: ONO-9054
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508988
ONO-9054IOU001
No
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Ono Pharma USA Inc
Not Provided
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP