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Healthy SubjectsPhase 1NCT01232413

A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy Subjects

A Phase 1 study testing ASP1941 and Moxifloxacin in people with Healthy Subjects and Cardiac Repolarization, run by Astellas Pharma Inc at 1 site 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 ASP1941 on electrocardiogram (ECG) measurements. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Cardiac Repolarization
What is being tested?
ASP1941 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteUnited States
Study dates
Sep 2010to Feb 2011
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject weighs at least 45 kg, and has a body mass index (BMI) of 18 to 32 kg/m2
  • If female, subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control, and not pregnant or lactating
  • The male or female subject agrees to practice highly effective birth control until 30 days post last study drug dose
  • The subject is highly likely to comply with the protocol-defined procedures and complete the study

Who cannot join

  • The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death due to cardiac causes at a young age of a close relative)
  • The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 72 hours prior to dosing and throughout the duration of the study
  • The subject has used tobacco-containing products and nicotine or nicotine-containing products within past six months
  • The subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance during specified times (e.g., prior to and in ECG extraction windows) 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 specified times (e.g., prior to ECG extraction windows), remaining quiet, awake, undistracted, motionless and supine during specified times, and avoiding vigorous exercise as directed
  • The subject is unable to tolerate study-specific diet
Show all 17Show fewer
  • The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
  • The subject has a history of clinically significant allergic conditions or anaphylactic reactions
  • The subject has any condition possibly affecting drug absorption
  • The subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years
  • The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous)infection within 1 week prior to clinic check in for any treatment period
  • The subject is known positive for human immunodeficiency virus (HIV) antibody
  • The subject has a positive test for hepatitis C antibody, or positive for hepatitis B antigen (HBsAg)
  • The subject has used prescription or non-prescription drugs within 14 days or 5-half lives (whichever is longer) or complementary and alternative medicines (CAM) within 28 days prior to Day -2 of Period 1 (excluding oral contraceptives, hormone replacement therapy [HRT], and acetaminophen)
  • The subject has received an experimental agent within 30 days or 10 half-lives, whichever is longer, prior to study drug administration
  • The subject is participating in another clinical trial or has participated in another dose group of the current trial
  • The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    West Bend, Wisconsin, 53095

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Repeat Oral Doses of ASP1941 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 ASP1941 on electrocardiogram (ECG) measurements.

Read the detailed description

Subjects will be randomized in four treatment sequences of twenty subjects each. Subjects in each treatment sequence will participate in a total of four treatment periods (A, B, C, and D) separated by washout periods of at least 7 days from completion of the prior period (Day 8) through clinical check-in (Day -1) of the next study period.

For Period 1, subjects will be admitted to the clinical research unit on Day -2. For each subsequent study period, subjects will be admitted to the clinical research unit on Day -1. Subjects will be discharged from the unit after completing procedures on Day 8 of each period. Subjects will receive a follow-up telephone call 7-10 days after their last clinic day (Period 4\Early Discontinuation [ED]).

Being tested
Placebo, ASP1941, Moxifloxacin
Keywords
Thorough QT (TQT), ASP1941

What participants receive

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

  • PlaceboDrug

    Oral

  • ASP1941Drug

    Oral

  • MoxifloxacinDrug

    Also called Avelox

    Oral

Study groups in NCT01232413
Study groupRoleWhat they receive
Treatment APlacebo comparatorPlacebo
Receives: Drug: Placebo
Treatment BExperimentalASP1941 low dose
Receives: Drug: ASP1941
Treatment CExperimentalASP1941 high dose
Receives: Drug: ASP1941
Treatment DActive comparatorMoxifloxacin
Receives: Drug: Moxifloxacin

What is being measured

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

  1. QTcF evaluated through electrocardiogram analysis (ECG)

    QTcF is a QT interval corrected for heart rate (Fridericia's formula)

    Measured: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

Secondary outcomes (3)

  1. Evaluation of Electrocardiogram (ECG)

    Measured: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

  2. QTcI evaluated through electrocardiogram analysis

    QTcI is a QT interval corrected for individual heart rate

    Measured: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

  3. QTcB evaluated through electrocardiogram analysis (ECG)

    QTcB is a QT interval corrected for heart rate (Bazett's formula)

    Measured: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

Timeline

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

  1. First posted2 Nov 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232413
Sponsor's protocol ID
1941-CL-0058
Status last verified
Feb 2011
First submitted
27 Oct 2010
Last updated
28 Feb 2011
Results posted
No
Data monitoring committee
No

Publications

  • Zhang W, Smulders R, Abeyratne A, Dietz A, Krauwinkel W, Kadokura T, Keirns J. Ipragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study. Clin Ther. 2013 Aug;35(8):1150-1161.e3. doi: 10.1016/j.clinthera.2013.06.009. Epub 2013 Aug 2.

    PubMed 23910665

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP1941 and Moxifloxacin in people with Healthy Subjects and Cardiac Repolarization, run by Astellas Pharma Inc at 1 site 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 28 Feb 2011. 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 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?

QTcF evaluated through electrocardiogram analysis (ECG) (time frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)). 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 NCT01232413, 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 28 Feb 2011.

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