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

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

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

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure
• Intervention / Treatment: Drug: Placebo; Drug: Mirabegron

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral
Experimental: Mirabegron	Drug: Mirabegron; oral; Other Names: YM178

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• Novack GD, Lewis RA, Vogel R, Sheth N, Swearingen D, Rasmussen S, Hantsbarger G, Martin NE. Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther. 2013 Sep;29(7):674-80. doi: 10.1089/jop.2012.0254. Epub 2013 Apr 15.

Helpful Links

• Link to Results on JAPIC

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: YM178; Intraocular Pressure (IOP)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: 178-CL-081