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

Astellas

Status and phase

Completed

Phase 1

Conditions

Intraocular Pressure

Treatments

Drug: Mirabegron

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

178-CL-081

Details and patient eligibility

About

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

Enrollment

321 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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