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

NCT01964183 | Completed Phase 4

• 1 other identifier: 178-CL-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics of Mirabegron and Tolterodine; Healthy

Keywords

Open-label design; Pharmacokinetics; Drug-Drug Interaction; Mirabegron

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of unchanged mirabegron

  Day 14

• Plasma concentration of unchanged tolterodine

  Day 7, Day 14

Secondary Outcomes (2)

• Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)

  Day 7, Day 14

• 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

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: tolterodine; Drug: mirabegron

Interventions

tolterodine DRUG

Oral

Also known as: Detrusitol® Capsules

treatment group

mirabegron DRUG

Oral

Also known as: YM178, Betanis® tablets

treatment group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kanto, Japan

Location

MeSH Terms

Interventions

Tolterodine Tartrate; mirabegron

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 17, 2013

Record last verified: 2013-10

Locations

JP (1)