Long QT SyndromePhase 1NCT02365532
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
A Phase 1 study testing GS-6615 and Dofetilide in people with Long QT Syndrome, run by Gilead Sciences at 1 site in United States.
Trial summary
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome
- What is being tested?
- GS-6615 and Dofetilide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
- Have a calculated body mass index (BMI) from 18 to 30 kg/m^2, inclusive, at study screening
- Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the QT interval in the opinion of the investigator in consultation with the medical monitor
Who cannot join
- History of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures
- Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
- Presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ECG and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction < 40%), presence of cardiac conduction abnormalities, a family history of Long QT or Brugada Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
- Additional cardiovascular-specific exclusion criteria include findings on screening ECG of:
- QTcF interval > 430 msec
- PR interval > 220 msec
Show all 14Show fewer
- QRS duration > 110 msec
- Second- or third-degree atrioventricular block
- Complete left or right bundle branch block or incomplete right bundle branch block
- Resting heart rate < 40 or > 100 beats per minute (bpm)
- Pathological Q waves (defined as Q wave > 40 msec)
- Ventricular pre-excitation
- More than 2 ectopic beats
- Syncope, palpitations, or unexplained dizziness
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Subjects
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.
- Conditions
- Long QT Syndrome
- Being tested
- GS-6615, Placebo to match GS-6615, Placebo to match dofetilide, Dofetilide
- Keywords
- drug-induced long QT syndrome, DILQTS, prolonged QT
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-6615Drug
GS-6615 tablets administered orally
Placebo to match GS-6615Drug
Placebo to match GS-6615 tablets administered orally
Placebo to match dofetilideDrug
Placebo to match dofetilide capsules administered orally
DofetilideDrug
Dofetilide 500 μg capsules administered orally according to the current prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Placebo to match GS-6615 | Placebo comparator | Placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily Receives: Drug: Placebo to match GS-6615; Drug: Placebo to match dofetilide; Drug: Dofetilide |
| GS-6615 | Experimental | GS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily Receives: Drug: GS-6615; Drug: Placebo to match GS-6615; Drug: Placebo to match dofetilide; Drug: Dofetilide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF)
Measured: Up to 6 days
Pharmacokinetic (PK) profiles of GS-6615 and dofetilide
This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC_0-24, and AUC_0-tlast.
Measured: Predose and postdose on Days -2 through Day 4
Secondary outcomes (1)
Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data
This endpoint will measure the safety and tolerability profile of GS-6615.
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly B Patel, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365532
- Sponsor's protocol ID
- GS-US-372-1666
- Status last verified
- May 2015
- First submitted
- 13 Feb 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02365532
- Acronym / sponsor ID
- GS-US-372-1666
- Conditions
- Long QT Syndrome
- Keywords
- drug-induced long QT syndrome, DILQTS, prolonged QT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Feb 2015 (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 study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo to match GS-6615 | Placebo comparator | Drug: Placebo to match GS-6615, Drug: Placebo to match dofetilide, Drug: DofetilidePlacebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily |
| GS-6615 | Experimental | Drug: GS-6615, Drug: Placebo to match GS-6615, Drug: Placebo to match dofetilide, Drug: DofetilideGS-6615 or placebo to match GS-6615 + dofetilide or placebo to match dofetilide twice daily |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
- Have a calculated body mass index (BMI) from 18 to 30 kg/m^2, inclusive, at study screening
- Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the QT interval in the opinion of the investigator in consultation with the medical monitor
Key exclusion criteria (14 listed)
- History of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures
- Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
- Presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ECG and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction < 40%), presence of cardiac conduction abnormalities, a family history of Long QT or Brugada Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
- Additional cardiovascular-specific exclusion criteria include findings on screening ECG of:
- Syncope, palpitations, or unexplained dizziness
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 |
|---|---|---|
| GS-6615GS-6615 tablets administered orally | Drug | GS-6615 |
| Placebo to match GS-6615Placebo to match GS-6615 tablets administered orally | Drug | GS-6615, Placebo to match GS-6615 |
| Placebo to match dofetilidePlacebo to match dofetilide capsules administered orally | Drug | GS-6615, Placebo to match GS-6615 |
| DofetilideDofetilide 500 μg capsules administered orally according to the current prescribing information | Drug | GS-6615, Placebo to match GS-6615 |
Primary outcome
Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF)
Time frame: Up to 6 days
Pharmacokinetic (PK) profiles of GS-6615 and dofetilide
Time frame: Predose and postdose on Days -2 through Day 4
This endpoint will measure the plasma PK profiles of GS-6615 and dofetilide. PK parameters that will be measured include Cmax, Tmax, AUC_0-24, and AUC_0-tlast.
1 secondary outcome
Incidence of adverse events, clinical laboratory test results, vital sign measurements, and electrocardiogram (ECG) data
Time frame: Up to 6 days
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 20 May 2015.
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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.
Kimberly B Patel, MD study director
Gilead Sciences
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 GS-6615 and Dofetilide in people with Long QT Syndrome, run by Gilead Sciences 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 3 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 20 May 2015. 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?
Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) (time frame: Up to 6 days). 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 20 May 2015.