Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

Healthy Clinical Trial

Official title:

Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964183
• Other study ID #: 178-CL-111
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2013
• Last updated: October 15, 2013
• Start date: June 2013
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites.

In addition, the safety of these products will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects of two years after menopause

• Body weight (at screening) = 40.0 kg and < 70.0 kg

• Body mass index (BMI) (at screening) = 17.6 kg/m2 and < 26.4 kg/m2

• Healthy, as judged by the investigator/sub-investigator based on medical history and the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission (at single dosing phase) to immediately before study medication.

Exclusion Criteria:

• Received or scheduled to receive any investigational drugs in other clinical trials, post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to hospitalization (Day -2).

• Donated or scheduled to donate 400 mL of whole blood within 90 days before the screening or during the period from the screening to hospitalization (Day -2), 200 mL of whole blood within 30 days before the screening or during the period from the screening to hospitalization (Day -2), or blood components within 14 days before the screening or during the period from the screening to hospitalization (Day -2).

• Any deviation of the laboratory tests at screening or hospitalization (Day -2).

• A deviation from the normal range of blood pressure, pulse rae, or body temperature at screening or hospitalization (Day -2) Supine blood pressure: Systolic blood pressure: =90 mmHg, =140 mmHg, Diastolic blood pressure: =40 mmHg, =90 mmHg Supine pulse rate; =40 bpm, =99 bpm Axillary body temperature; =35.0°C, =37.0°C

• History of drug allergies

• Upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before hospitalization (Day -2)

• Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury, and hepatic impairment)

• Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)

• Concurrent or previous GI disease (e.g., ileus paralytic, gastric atony, intestinal atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).

• Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)

• Concurrent or previous endocrine disease (e.g., hyperthyroidism and blood growth hormone abnormal)

• Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)

• Previous use of mirabegron or tolterodine

• Excessive smoking or drinking habit

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of Mirabegron and Tolterodine

Intervention

Drug:
• tolterodine
Oral
• mirabegron
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of unchanged mirabegron		Day 14	No
Primary	Plasma concentration of unchanged tolterodine		Day 7, Day 14	No
Secondary	Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)		Day 7, Day 14	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG		Day -2, Day 8, Day 15, Day 22	No