Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508988
• Other study ID #: ONO-9054IOU001
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: June 12, 2012
• Start date: January 2012

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• ONO-9054
Eye drops 0.3 µg/mL both eyes on Day one
• ONO-9054
Eye drops 1 µg/mL both eyes on Day one
• ONO-9054
Eye drops 3 µg/mL both eyes on Day one
• ONO-9054
Eye drops 10 µg/mL both eyes on Day one
• ONO-9054
Eye drops 20 µg/mL both eyes on Day one
• ONO-9054
Eye drops 30 µg/mL both eyes on Day one
• ONO-9054
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one

Locations

Country	Name	City	State
United States	Covance Phase 1 Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample		up to 2 days	No
Secondary	2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering		up to 2 days	No