ArrhythmiaPhase 1NCT00543946
Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males
A Phase 1 study testing GAP-134 in people with Arrhythmia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Japan.
Trial summary
This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after administration of ascending single intravenous (IV) doses to healthy Japanese male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia
- What is being tested?
- GAP-134
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Mar 2008
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese men age 20-45.
- BMI within 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking within 48 hours before study day 1 until the end of the inpatient confinement period.
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).
- Acute disease state.
- Any history of clinically important cardiac arrhythmias. Family history of long QT syndrome, Torsades de Pointes or unexpected cardiac death.
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. Creatinine levels must be less than or equal to the upper limit of normal at screening.
- Demonstration of a positive orthostatic test at screening. The definition of a positive test is a greater than or equal to 20 mm Hg decrease in systolic blood pressure, greater than or equal to 10 mm Hg decrease in diastolic blood pressure, or a greater than or equal to 30 bpm increase in pulse rate, after standing for 3 minutes.
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- Positive serologic findings for human immunodeficiency virus (HIV) antigen and antibodies, hepatitis B surface antigen (HbsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings of urine drug screen.
- History of any clinically important drug allergy or adverse drug reaction (e.g., relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles or angioedemas)
- Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1.
- Consumption of any caffeine-containing products.
- Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 until the end of the inpatient confinement period.
- Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins less than or equal to 100% of the recommended daily allowance), within 14 days before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascending Single Dose Study of The Safety, Tolerability, Pharmacokinetics, of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Japanese Male Subjects
This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.
Read the detailed description
Atrial Fibrillation (AF) is the most commonly occurring sustained arrhythmia in clinical practice. AF is a serious disorder associated with an increased risk of stroke, morbidity and mortality, and the number of patients is estimated to double within the next 4 decades. The currently available antiarrhythmic drugs have limited efficacy and are associated with serious side effects of which potentially lethal ventricular proarrhythmias are one of the major concerns. Thus, there is a large unmet clinical need for efficacious and safe antiarrhythmic drugs for the treatment of AF.
The classical orientation of antiarrhythmic therapy has been to modulate cardiac ion channels (sodium, potassium or calcium) or the autonomic nervous system. However, numerous experimental and clinical studies have suggested that cardiac conduction slowing and impaired gap junction intercellular communication (GJIC) are important in the pathogenesis of cardiac arrhythmias, including AF. General conduction slowing or the presence of small islands of intra-atrial conduction block resulting from a decreased gap junction conductance, altered gap junction expression and heterogeneous spatial distribution of gap junctions may provide turning points for the multiple waves, and thereby promote re-entry of impulses. In recognition of this, several authors have proposed gap junction modulation as a potential new target in the treatment of AF. GAP-134 is an antiarrhythmic dipeptide that has demonstrated in vitro and in vivo efficacy in mouse and dog models of arrhythmia. GAP-134 has no apparent proarrhythmic activity or hemodynamic compromise and does not show any significant binding in a panel of >60 different receptors and ion channels. If determined to be safe and effective the indication sought for GAP-134 will be the prevention of post operative atrial fibrillation.
- Conditions
- Arrhythmia
- Being tested
- GAP-134
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAP-134Drug
24-Hour IV infusion, SAD
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the safety and tolerability of ascending, single IV doses of GAP-134 as 24-hour continuous infusions and as a single bolus injection in healthy Japanese male subjects.
Measured: 6 months
Secondary outcomes (1)
The secondary objective is to provide the initial PK profiles of ascending single IV doses (24 hour and 1-minute) of GAP-134 taken under fasting conditions in healthy Japanese male subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543946
- Sponsor's protocol ID
- 3205K2-1002
- Status last verified
- Sep 2018
- First submitted
- 11 Oct 2007
- Last updated
- 27 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study of The Safety, Tolerability, Pharmacokinetics, of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT00543946
- Acronym / sponsor ID
- 3205K2-1002
- Conditions
- Arrhythmia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Oct 2007 (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.
This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.
Detailed description
Atrial Fibrillation (AF) is the most commonly occurring sustained arrhythmia in clinical practice. AF is a serious disorder associated with an increased risk of stroke, morbidity and mortality, and the number of patients is estimated to double within the next 4 decades. The currently available antiarrhythmic drugs have limited efficacy and are associated with serious side effects of which potentially lethal ventricular proarrhythmias are one of the major concerns. Thus, there is a large unmet clinical need for efficacious and safe antiarrhythmic drugs for the treatment of AF.
The classical orientation of antiarrhythmic therapy has been to modulate cardiac ion channels (sodium, potassium or calcium) or the autonomic nervous system. However, numerous experimental and clinical studies have suggested that cardiac conduction slowing and impaired gap junction intercellular communication (GJIC) are important in the pathogenesis of cardiac arrhythmias, including AF. General conduction slowing or the presence of small islands of intra-atrial conduction block resulting from a decreased gap junction conductance, altered gap junction expression and heterogeneous spatial distribution of gap junctions may provide turning points for the multiple waves, and thereby promote re-entry of impulses. In recognition of this, several authors have proposed gap junction modulation as a potential new target in the treatment of AF. GAP-134 is an antiarrhythmic dipeptide that has demonstrated in vitro and in vivo efficacy in mouse and dog models of arrhythmia. GAP-134 has no apparent proarrhythmic activity or hemodynamic compromise and does not show any significant binding in a panel of >60 different receptors and ion channels. If determined to be safe and effective the indication sought for GAP-134 will be the prevention of post operative atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese men age 20-45.
- BMI within 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking within 48 hours before study day 1 until the end of the inpatient confinement period.
Key exclusion criteria (13 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).
- Acute disease state.
- Any history of clinically important cardiac arrhythmias. Family history of long QT syndrome, Torsades de Pointes or unexpected cardiac death.
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. Creatinine levels must be less than or equal to the upper limit of normal at screening.
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 |
|---|---|---|
| GAP-13424-Hour IV infusion, SAD | Drug | – |
Primary outcome
The primary objective is to assess the safety and tolerability of ascending, single IV doses of GAP-134 as 24-hour continuous infusions and as a single bolus injection in healthy Japanese male subjects.
Time frame: 6 months
1 secondary outcome
The secondary objective is to provide the initial PK profiles of ascending single IV doses (24 hour and 1-minute) of GAP-134 taken under fasting conditions in healthy Japanese male subjects.
Time frame: 6 months
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 27 Sep 2018.
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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 Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GAP-134 in people with Arrhythmia, run by Wyeth is now a wholly owned subsidiary of Pfizer 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 3 inclusion and 13 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 27 Sep 2018. 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 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?
The primary objective is to assess the safety and tolerability of ascending, single IV doses of GAP-134 as 24-hour continuous infusions and as a single bolus injection in healthy Japanese male subjects. (time frame: 6 months). 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 27 Sep 2018.