A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions

NCT ID: NCT01646294

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-05-31

Brief Summary

The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.

Detailed Description

Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast).

The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.

Conditions

Pharmacokinetics of YM178; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

OCAS-F

YM178 OCAS tablet (OCAS-Fast) taken orally under fasted and fed condition

Group Type: EXPERIMENTAL

YM178 modified release (OCAS)

Intervention Type: DRUG

oral

YM178 immediate release (IR)

Intervention Type: DRUG

oral

OCAS-S

YM178 OCAS tablet (OCAS-Slow) taken orally under fasted and fed condition

Group Type: EXPERIMENTAL

YM178 modified release (OCAS)

Intervention Type: DRUG

oral

YM178 immediate release (IR)

Intervention Type: DRUG

oral

OCAS-M

YM178 OCAS tablet (OCAS-Medium) taken orally under fasted and fed condition

Group Type: EXPERIMENTAL

YM178 modified release (OCAS)

Intervention Type: DRUG

oral

YM178 immediate release (IR)

Intervention Type: DRUG

oral

Interventions

YM178 modified release (OCAS)

oral

Intervention Type: DRUG

YM178 immediate release (IR)

oral

Intervention Type: DRUG

Other Intervention Names

mirabegron; Myrebtriq; mirabegron; Myrebtriq

Eligibility Criteria

Inclusion Criteria

• Body weight between 60.0 and 100.0 kg, and BMI between 18.0 and 30.0 kg/m2

Exclusion Criteria

• Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
• Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine and/or abnormal serum bilirubin
• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
• Any clinically significant history of upper gastrointestinal symptoms in the 4 weeks prior to the first admission to the Research Unit
• Any clinically significant history of any other disease or disorder -gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
• QTcB interval of >430 msec at screening (mean QTcB of two measurements>430msec)
• Abnormal pulse rate measurement (<40 or >90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min
• Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 minutes
• Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of > 20 mmHg in systolic blood pressure after 2 min standing (as outlined in section 12.5) and an increase in pulse rate of ≥ 20 bpm
• History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to first admission to the Research Unit.
• History of drinking more than 21 units of alcohol per week within 3 months prior to first admission to the Research Unit
• Donation of blood or blood products (more than 400 ml) within 3 months prior to first admission to the Research Unit or plasmapheresis within 4 weeks preceding the start of this study
• Positive serology test for HBsAg, HAV IgM, anti-HCV or anti-HIV 1+2
• Subject who is not willing to complete standard FDA high fat breakfast

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Pharma Bio-Research B.V.

Zuidlaren, , Netherlands

Countries

Netherlands

References

Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014.

Reference Type: BACKGROUND

PMID: 23497763 (View on PubMed)

Other Identifiers

2004-003876-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-030

Identifier Type: -

Identifier Source: org_study_id