A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.

Official Title
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A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Drug: Mirabegron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report Exclusion Criteria: History of glaucoma or ocular hypertension Abnormal visual field in either eye Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye Ocular trauma within the past six months Severe myopia Diabetes, Type I or Type 2, with or without medical management Cardiovascular disease requiring pharmacotherapy History of any type of dysrhythmia Systemic hypertension requiring pharmacotherapy Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies History of psychiatric illness requiring hospitalization Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine) Used tobacco-containing products or nicotine-containing products within past 3 months Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time Ocular medication of any kind within past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirabegron<br> | Drug: Mirabegron<br>* oral<br>* Other names: YM178;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in subject-average intraocular pressure (IOP) | Day 56 data will include subjects who discontinue early due to elevated IOP | Baseline and Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 10 in subject-average IOP |  | Baseline and Day 10 | 
| Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10 |  | Baseline and Day 10 | 
| Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56 |  | Baseline and Day 56 | 
| Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10 |  | Baseline and Day 10 | 
| Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56 |  | Baseline and Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Pressure (IOP), YM178