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

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of YM178

Treatments

Drug: rifampin

Drug: mirabegron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00776516

178-CL-070

Details and patient eligibility

About

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.

Full description

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

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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