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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00776516
First received: October 20, 2008
Last updated: July 1, 2013
Last verified: July 2013

October 20, 2008
July 1, 2013
October 2008
December 2008   (final data collection date for primary outcome measure)
Assess pharmacokinetics of mirabegron alone and in combination with rifampin [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776516 on ClinicalTrials.gov Archive Site
Assess safety and tolerability of mirabegron alone and in combination with rifampin [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers
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)

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pharmacokinetics of YM178
  • Drug: mirabegron
    oral
    Other Name: YM178
  • Drug: rifampin
    oral
    Other Name: Rifadin
  • Experimental: 1
    mirabegron alone
    Intervention: Drug: mirabegron
  • Experimental: 2
    mirabegron and rifampin
    Interventions:
    • Drug: mirabegron
    • Drug: rifampin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00776516
178-CL-070
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
July 2013

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