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Healthy SubjectsPhase 1NCT01199523

A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females

A Phase 1 study testing mirabegron and moxifloxacin in people with Healthy Subjects, run by Astellas Pharma Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
mirabegron and moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
2 sitesUnited States
Study dates
May 2010to Nov 2010
Phase
Phase 1
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 28.5 kg/m2, inclusive
  • The female subject must be post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month prior to screening). All women of child bearing potential will be required to use adequate contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative serum pregnancy test. Male subjects with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period and for 30 days after final study drug administration.
  • The subject must have negative test results for drugs of abuse and alcohol screens
  • The subject must have good venous access

Who cannot join

  • The subject is known to have hypersensitivity to mirabegron, or other adrenoreceptor agonists, or any of the constituents of the formulation used, or moxifloxacin or any member of the quinolone class of antimicrobial agents
  • The subject has a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, structural heart disease, valvular abnormalities, or family history of long QT syndrome
  • The subject has experienced acute febrile illness within past 7 days
  • The subject has a history of tendonitis and/or liver function abnormality related to quinolone antibiotic treatment
  • The subject has a hyperthyroid disorder
  • The subject has a history or presence of psychiatric illness, or any medical condition or disorder that may compromise evaluation of drug effect, or is incapable of being compliant with the study procedures
Show all 17Show fewer
  • 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 prior to Day -4 of Period 1 (within 30 days prior to Day -4 of Period 1 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 hormonal contraceptives not including depot formulations, hormone replacement therapy and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days prior to Day -4 of Period 1
  • The subject has consumed alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit on Day -4 of Period 1
  • The subject has a recent history of alcohol or other substance abuse or any history of alcohol or substance dependence (with the exception of nicotine). The subject consumes more than 5 units of alcoholic beverages per week
  • The subject has used tobacco-containing products or nicotine-containing products within 6 months
  • The subject is currently participating in another clinical trial or is taking or has been taking an investigational drug 30 days or 10 half lives (whichever is longer), prior to first study drug administration
  • The subject is known to have hepatitis or human immunodeficiency virus (HIV)-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody
  • The subject has any skin condition likely to interfere with electrocardiographic electrode placement or adhesion
  • The subject has a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
  • The subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance during specified times (e.g., during ECG monitoring days) of music, TV, movies, games and activities that may cause excitement, emotional tension or arousal
  • The subject is unwilling to comply with study rules, including attempting to void at restricted times (e.g., prior to ECG extraction windows), remaining quiet, awake, undistracted, motionless and supine during specified times, and avoiding vigorous exercise as directed

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Baltimore, Maryland, 21225

  • Study site

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo and Active Controlled, Parallel Crossover Study to Evaluate the Effect of Repeat Oral Doses of Mirabegron on Cardiac Repolarization in Healthy Male and Female Adult Subjects

The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.

Read the detailed description

Each subject will be randomized and participate in two 10-day treatment periods during which once daily dosing of mirabegron and mirabegron/moxifloxacin placebo or moxifloxacin and moxifloxacin/mirabegron placebo will occur followed by a 1-day post-treatment period. Each treatment period will be separated by a washout period of at least 12 days from the last dose of study drug on Day 10 of Period 1 to Day -4 of Period 2.

Being tested
Placebo, mirabegron, moxifloxacin
Keywords
YM178, Mirabegron, QT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    oral

  • mirabegronDrug

    Also called YM178

    oral

  • moxifloxacinDrug

    Also called Avelox

    oral

Study groups in NCT01199523
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
mirabegron high doseExperimentalNot described
Receives: Drug: mirabegron
mirabegron medium doseExperimentalNot described
Receives: Drug: mirabegron
mirabegron low doseExperimentalNot described
Receives: Drug: mirabegron
moxifloxacinActive comparatorNot described
Receives: Drug: moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QTcl evaluated through electrocardiogram analysis

    QTcI is a QT interval corrected for heart rate using individual-specific correction formula

    Measured: Day 1 to Day 11 in Treatment Period 1 and 2

Secondary outcomes (1)

  1. Pharmacodynamic assessment through electrocardiogram analysis

    Measured: Day 1 to Day 11 in Treatment Period 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

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 1
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199523
Sponsor's protocol ID
178-CL-077
Status last verified
Jul 2013
First submitted
9 Sep 2010
Last updated
3 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R, Mujais SK, Schaddelee MP, de Koning P, Kaibara A, Moy SS, Keirns JJ. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study. Clin Pharmacol Ther. 2012 Dec;92(6):696-706. doi: 10.1038/clpt.2012.181. Epub 2012 Nov 14.

    PubMed 23149929

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mirabegron and moxifloxacin in people with Healthy Subjects, run by Astellas Pharma Inc at 2 sites in United States.

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 17 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 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

QTcl evaluated through electrocardiogram analysis (time frame: Day 1 to Day 11 in Treatment Period 1 and 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199523, which also lists 1 linked publication.

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 3 Jul 2013.

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