Clinical trial NCT01334905: A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics of YM178
Keywords: Overactive Bladder
Urinary incontinence
YM178
mirabegron
Food effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2011-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of YM178
timeFrame: Up to 96 hrs post dose
measure: AUC (area under the curve) of YM178 plasma concentration
timeFrame: Up to 96 hrs post dose
Secondary outcomes:
measure: tmax of YM178 plasma concentration
timeFrame: Up to 96 hrs post dose
measure: t1/2 of YM178 plasma concentration
timeFrame: Up to 96 hrs post dose
measure: Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam.
timeFrame: Up to 96 hrs post dose
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: