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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01334905
First received: April 12, 2011
Last updated: June 10, 2013
Last verified: October 2011

April 12, 2011
June 10, 2013
March 2011
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01334905 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Healthy Volunteer
  • Pharmacokinetics of YM178
Drug: YM178
oral
Other Name: mirabegron
  • Experimental: Part A group
    fasted condition then fed condition
    Intervention: Drug: YM178
  • Experimental: Part B group
    fed condition then fasted condition
    Intervention: Drug: YM178
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01334905
178-CL-092
No
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP