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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334905
• Other study ID #: 178-CL-092
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2011
• Last updated: June 10, 2013
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics of YM178

Intervention

Drug:
• YM178
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

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

External Links

•   Link to Results on JAPIC