Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01334905
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01334905
Study Brief:
Protocol Section:
NCT01334905