Healthy Volunteer, Pharmacokinetics of YM178
Conditions
Keywords
Overactive Bladder, Urinary incontinence, YM178, mirabegron, Food effect
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.
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.
Interventions
DRUGYM178
oral
Sponsors
Astellas Pharma Taiwan, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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 |
Countries
Taiwan
Outcome results
None listed