Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Pharmacokinetics of Mirabegron	Drug: mirabegron	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Assess the Pharmacokinetics of Mirabegron Modified Formulations With Different Release Rates Versus IV Infusion in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Mirabegron

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the safety and tolerability of three doses of orally administered mirabegron formulated with three different release rates [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Assess the safety and tolerability of intravenously administered mirabegron [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	April 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. mirabegron, low dose	Drug: mirabegron oral tablet Other Name: YM178 Drug: mirabegron IV solution Other Name: YM178
Experimental: 2. mirabegron, middle dose	Drug: mirabegron oral tablet Other Name: YM178 Drug: mirabegron IV solution Other Name: YM178
Experimental: 3. mirabegron, higher dose	Drug: mirabegron oral tablet Other Name: YM178 Drug: mirabegron IV solution Other Name: YM178

Detailed Description:

Subjects will be randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of six treatment sequences.

For all subjects the first treatment will be a reference IV dose. Treatments 2, 3, and 4 will be a random order of slow, fast and target release oral doses of mirabegron. Treatment 5 will be a target release dose of mirabegron from a different batch.

There will be at least 10 day washout between dose administrations.

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940121

Locations

United States, Washington

Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 β₃-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.

Responsible Party:	Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00940121 History of Changes
Other Study ID Numbers:	178-CL-076
Study First Received:	July 13, 2009
Last Updated:	August 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Healthy volunteer subjects
pharmacokinetics
YM178

mirabegron
IV infusion
oral administration

ClinicalTrials.gov processed this record on May 16, 2013