Clinical trial NCT01964183: Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine
Official title: Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacokinetics of Mirabegron and Tolterodine
Healthy
Keywords: Open-label design
Pharmacokinetics
Drug-Drug Interaction
Mirabegron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of unchanged mirabegron
timeFrame: Day 14
measure: Plasma concentration of unchanged tolterodine
timeFrame: Day 7, Day 14
Secondary outcomes:
measure: Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)
timeFrame: Day 7, Day 14
measure: Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG
timeFrame: Day -2, Day 8, Day 15, Day 22
Other outcomes:
Locations:
city: Kanto
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_CHAIR
References: