Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron

NCT00940121 | Completed Phase 1

• 1 other identifier: 178-CL-076
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron formulations with three different release rates versus three doses of mirabegron administered intravenously; to study safety and side effects of the oral and IV doses of mirabegron.

Conditions

Healthy; Pharmacokinetics of Mirabegron

Keywords

oral administration; YM178; IV infusion; pharmacokinetics; mirabegron; Healthy volunteer subjects

Outcome Measures

Primary Outcomes (1)

• Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously

  2 months

Secondary Outcomes (2)

• Assess the safety and tolerability of three doses of orally administered mirabegron formulated with three different release rates

  2 months

• Assess the safety and tolerability of intravenously administered mirabegron

  2 months

Study Arms (3)

1. mirabegron, low dose

EXPERIMENTAL

Oral mirabegron 25 mg

Drug: mirabegron

2. mirabegron, middle dose

EXPERIMENTAL

Oral mirabegron 50 mg

Drug: mirabegron

3. mirabegron, higher dose

EXPERIMENTAL

Oral mirabegron 100 mg

Drug: mirabegron

Interventions

mirabegron DRUG

oral tablet

Also known as: YM178

1. mirabegron, low dose; 2. mirabegron, middle dose; 3. mirabegron, higher dose

Eligibility Criteria

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

You may qualify if:

• The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2
• The subject must have a normal or clinically nonsignificant 12 lead ECG as well as normal or clinically non-significant laboratory test results
• Female subjects must be post-menopausal (defined as at least 2 years without menses) surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and should have a negative pregnancy test result
• The subject must have negative test results for drugs of abuse and alcohol screens
• The subject must have a good venous access in both arms

You may not qualify if:

• The subject has evidence of QTc interval \>430 msec for male, \>450 msec for female
• The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
• The subject has a history or presence of psychiatric illness, serious active or recurrent infection
• The subject has a 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
• The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
• The subject has received or is anticipated to receive a prescription drug within 14 days (within 30 days for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
• The subject has consumed alcohol, xanthine derivative-containing beverages/food (tea/chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
• The subject has used tobacco-containing products and nicotine-containing products within 6 months
• The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
• The subject is 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

Related Publications (1)

• Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J, van Marle S, Grunenberg N, Kowalski D, Drogendijk T, Moy S, Iitsuka H, van Gelderen M, Matsushima H, Sawamoto T. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a beta(3)-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.

  PMID: 22943933 BACKGROUND

MeSH Terms

Interventions

mirabegron

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 15, 2009
• Study Start: April 30, 2009
• Primary Completion: July 13, 2009
• Study Completion: July 13, 2009
• Last Updated: October 16, 2024

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)