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Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01508988
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE January 12, 2012
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01508988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample [ Time Frame: up to 2 days ]
  • 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering [ Time Frame: up to 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
Official Title  ICMJE A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Adult Subjects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508988
Other Study ID Numbers  ICMJE ONO-9054IOU001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Study Sponsor  ICMJE Ono Pharma USA Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date June 2012

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