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

NCT00776516 | Completed Phase 1

• 1 other identifier: 178-CL-070
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics of YM178

Keywords

Healthy volunteer subjects; CYP3A4 inducer; rifampin; drug interaction; pharmacokinetics; YM178; mirabegron

Outcome Measures

Primary Outcomes (1)

• Assess pharmacokinetics of mirabegron alone and in combination with rifampin

  One month

Secondary Outcomes (1)

• Assess safety and tolerability of mirabegron alone and in combination with rifampin

  one month

Study Arms (2)

1

EXPERIMENTAL

mirabegron alone

Drug: mirabegron

2

EXPERIMENTAL

mirabegron and rifampin

Drug: mirabegron; Drug: rifampin

Interventions

mirabegron DRUG

oral

Also known as: YM178

1; 2

rifampin DRUG

oral

Also known as: Rifadin

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

Related Publications (1)

• 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 beta3-adrenoceptor agonist. Clin Drug Investig. 2013 Jun;33(6):429-40. doi: 10.1007/s40261-013-0084-y.

  PMID: 23625188 BACKGROUND

MeSH Terms

Interventions

mirabegron; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

US (1)