Healthy Volunteer Clinical Trial
Official title:
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
Verified date | October 2011 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Taiwan, Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum plasma concentration (Cmax) of YM178 | Up to 96 hrs post dose | No | |
Primary | AUC (area under the curve) of YM178 plasma concentration | Up to 96 hrs post dose | No | |
Secondary | tmax of YM178 plasma concentration | Up to 96 hrs post dose | No | |
Secondary | t1/2 of YM178 plasma concentration | Up to 96 hrs post dose | No | |
Secondary | 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 | No |
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