Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers - Full Text View

Purpose

The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.

Condition	Intervention	Phase
Pharmacokinetics of YM178	Drug: mirabegron Drug: rifampin	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178)

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Rifampin Mirabegron

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assess pharmacokinetics of mirabegron alone and in combination with rifampin [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess safety and tolerability of mirabegron alone and in combination with rifampin [ Time Frame: one month ] [ Designated as safety issue: No ]


Enrollment:	24
Study Start Date:	October 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 mirabegron alone	Drug: mirabegron oral Other Name: YM178
Experimental: 2 mirabegron and rifampin	Drug: mirabegron oral Other Name: YM178 Drug: rifampin oral Other Name: Rifadin

Detailed Description:

A single group of patients will receive both mirabegron alone and in combination with rifampin

Eligibility


Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Weighs at least 45 kg and body mass index (BMI) between 18 and 32 kg/m2 at Screening
Normal or not clinically significant 12 lead ECG and clinical laboratory test results at Screening
Female subjects must be post-menopausal, surgically sterile since at least 1 month prior to screening, or practicing effective non-hormonal contraceptive methods. All females must be non-lactating, and should have a negative result for the pregnancy test at Screening and on Day -1
Negative drug and alcohol screens

Exclusion Criteria:

Has known or suspected hypersensitivity to mirabegron or rifampin
Liver enzyme test abnormalities (ALT, AST, or bilirubin) above the upper limit of normal
History or presence of psychiatric illness, serious active or recurrent infection or hepatitis
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 dose of study drug
Donation or loss of ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
Received or is anticipated to receive a prescription drug within 14 days prior to Day -1 or within 30 days prior to Day -1 for any long acting treatments. Use of any over-the-counter medications, including complementary and alternative medicines (except for occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days prior to Day -1
History of substance abuse within 6 months prior to Screening
Current participation in another clinical trial or is taking or has been taking an investigational drug in the 30 days or 10 half lives of the drug, whichever is longer, prior to dosing
Known to have hepatitis or HIV-1 and/or HIV-2 or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at Screening
Subject has consumed alcohol, caffeine-containing food or beverages, grapefruit juice, grapefruit-containing products or Seville oranges within 48 prior to Day -1

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776516

Locations


United States, Florida

Miami, Florida, United States, 33126

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Central Contact	Astellas Pharma Global Development

More Information

Additional Information:

Link to Results on JAPIC This link exits the ClinicalTrials.gov site

Publications:

Lee J, Moy S, Meijer J, Krauwinkel W, Sawamoto T, Kerbusch V, Kowalski D, Roy M, Marion A, Takusagawa S, van Gelderen M, Keirns J. Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a β3-adrenoceptor agonist. Clin Drug Investig. 2013 Jun;33(6):429-40. doi: 10.1007/s40261-013-0084-y.


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00776516 History of Changes
Other Study ID Numbers:	178-CL-070
Study First Received:	October 20, 2008
Last Updated:	July 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:


Healthy volunteer subjects CYP3A4 inducer rifampin drug interaction	pharmacokinetics YM178 mirabegron

Additional relevant MeSH terms:


Mirabegron Rifampin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents Cholinergic Agents Cholinergic Antagonists Enzyme Inhibitors	Leprostatic Agents Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists Neurotransmitter Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Urological Agents

ClinicalTrials.gov processed this record on March 02, 2015