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Completed

NCT Number: NCT01508988

Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Phase 1 Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-9054

Drug

Eye drops 0.3 µg/mL both eyes on Day one

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering

    Time frame: up to 2 days

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
First posted
Jan 12, 2012
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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