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

• Maximum plasma concentration (Cmax) of YM178 [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
• AUC (area under the curve) of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]

• tmax of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
• t1/2 of YM178 plasma concentration [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]
• Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam. [ Time Frame: Up to 96 hrs post dose ] [ Designated as safety issue: No ]

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.

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.

• Healthy Volunteer
• Pharmacokinetics of YM178

• Experimental: Part A group
  fasted condition then fed condition
  Intervention: Drug: YM178
• Experimental: Part B group
  fed condition then fasted condition
  Intervention: Drug: YM178

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