A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers

A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers

The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Pharmacokinetics of YM178
• Intervention / Treatment: Drug: YM178

Detailed Description

A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening
• Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2
• All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control

Exclusion Criteria:

• Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used
• Liver function test values above the upper limit of normal
• A history or presence of psychiatric illness, serious active or recurrent infection
• A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study
• Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study
• Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study
• Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study
• A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study
• currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A group; fasted condition then fed condition	Drug: YM178; oral; Other Names: mirabegron
Experimental: Part B group; fed condition then fasted condition	Drug: YM178; oral; Other Names: mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of YM178	Up to 96 hrs post dose
AUC (area under the curve) of YM178 plasma concentration	Up to 96 hrs post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax of YM178 plasma concentration	Up to 96 hrs post dose
t1/2 of YM178 plasma concentration	Up to 96 hrs post dose
Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.	Up to 96 hrs post dose

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Taiwan, Inc.

Publications and helpful links

Helpful Links

• Link to Results on JAPIC

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Urinary incontinence; Food effect; Overactive Bladder; YM178; mirabegron
• 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-092