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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Mirabegron

Criteria

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