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

NCT01334905 | Completed Phase 1

• 1 other identifier: 178-CL-092
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer; Pharmacokinetics of YM178

Keywords

Overactive Bladder; Urinary incontinence; YM178; mirabegron; Food effect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Part A group

EXPERIMENTAL

fasted condition then fed condition

Drug: YM178

Part B group

EXPERIMENTAL

fed condition then fasted condition

Drug: YM178

Interventions

YM178 DRUG

oral

Also known as: mirabegron

Part A group; Part B group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 13, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 12, 2013

Record last verified: 2011-10

Locations

TW (1)