Pharmacokinetics of Mirabegron and TolterodinePhase 4NCT01964183
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine
A Phase 4 study testing tolterodine and mirabegron in people with Pharmacokinetics of Mirabegron and Tolterodine and Healthy, run by Astellas Pharma Inc at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Mirabegron and Tolterodine, Healthy
- What is being tested?
- tolterodine and mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine -
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.
- Being tested
- tolterodine, mirabegron
- Keywords
- Open-label design, Pharmacokinetics, Drug-Drug Interaction, Mirabegron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolterodineDrug
Also called Detrusitol® Capsules
Oral
mirabegronDrug
Also called YM178, Betanis® tablets
Oral
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: tolterodine; Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of unchanged mirabegron
Measured: Day 14
Plasma concentration of unchanged tolterodine
Measured: Day 7, Day 14
Secondary outcomes (2)
Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)
Measured: Day 7, Day 14
Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG
Measured: Day -2, Day 8, Day 15, Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of Mirabegron and TolterodineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964183
- Sponsor's protocol ID
- 178-CL-111
- Status last verified
- Oct 2013
- First submitted
- 15 Oct 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine -
- ClinicalTrials.gov ID
- NCT01964183
- Acronym / sponsor ID
- 178-CL-111
- Keywords
- Open-label design, Pharmacokinetics, Drug-Drug Interaction, Mirabegron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: tolterodine, Drug: mirabegron |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolterodineAlso: Detrusitol® CapsulesOral | Drug | treatment group |
| mirabegronAlso: YM178, Betanis® tabletsOral | Drug | treatment group |
Primary outcome
Plasma concentration of unchanged mirabegron
Time frame: Day 14
Plasma concentration of unchanged tolterodine
Time frame: Day 7, Day 14
2 secondary outcomes
Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)
Time frame: Day 7, Day 14
Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG
Time frame: Day -2, Day 8, Day 15, Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study chair
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tolterodine and mirabegron in people with Pharmacokinetics of Mirabegron and Tolterodine and Healthy, run by Astellas Pharma Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of unchanged mirabegron (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.