Abnormalities, CardiovascularPhase 1NCT02910635
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
A Phase 1 study testing Volanesorsen and Moxifloxacin in people with Abnormalities, Cardiovascular, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormalities, Cardiovascular
- What is being tested?
- Volanesorsen and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2016to 20 Dec 2016
- 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
- Must have given written informed consent and be able to comply with all study requirements
- Males and females aged 18-55 at the time of informed consent
- Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method
- Males must be surgically sterile, abstinent or using an acceptable contraceptive method
- The subject has a BMI of 19 to 32 kg/m^2 inclusive
- Consumption of nicotine or nicotine-containing products for at least 6 months before Screening
Who cannot join
- History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia
- Abnormal screening ECG
- Use of concomitant medications unless authorized by the Sponsor Medical Monitor
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- Treatment with another Study Drug, biological agent, or device within one-month of Screening
- Tests positive for drugs of abuse or cotinine
- Considered unsuitable for inclusion by the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study
The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.
- Conditions
- Abnormalities, Cardiovascular
- Being tested
- Volanesorsen, Moxifloxacin, Placebo
- Keywords
- Thorough QTc, Therapeutic dose, supra therapeutic dose
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolanesorsenDrug
ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
MoxifloxacinDrug
Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Volanesorsen, Intravenous (IV) | Experimental | 300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose Receives: Drug: Volanesorsen |
| Volanesorsen, Subcutaneous (SQ) | Experimental | 300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose Receives: Drug: Volanesorsen |
| Moxifloxacin Hydrochloride | Active comparator | Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose Receives: Drug: Moxifloxacin |
| Placebo Intravenous (IV) single dose | Placebo comparator | Administered as normal saline (0.9% Sodium Chloride) Receives: Drug: Placebo |
| Placebo Subcutaneous (SC) single dose | Placebo comparator | Administered as normal saline (0.9% Sodium Chloride) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)
ECG monitoring up to 24 hours post dose
Measured: 24 Hours
Secondary outcomes (1)
Placebo corrected change from baseline heart rate (HR, PR and QRS)
ECG monitoring 24 hours post dose
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start19 Sep 2016
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities, CardiovascularStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akcea Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910635
- Sponsor's protocol ID
- ISIS 304801-CS13
- Status last verified
- Jan 2022
- First submitted
- 9 Sep 2016
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study
- ClinicalTrials.gov ID
- NCT02910635
- Acronym / sponsor ID
- ISIS 304801-CS13
- Conditions
- Abnormalities, Cardiovascular
- Keywords
- Thorough QTc, Therapeutic dose, supra therapeutic dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Akcea Therapeutics
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 22 Sep 2016 (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.
The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Volanesorsen, Intravenous (IV) | Experimental | Drug: Volanesorsen300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose |
| Volanesorsen, Subcutaneous (SQ) | Experimental | Drug: Volanesorsen300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose |
| Moxifloxacin Hydrochloride | Active comparator | Drug: MoxifloxacinMoxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose |
| Placebo Intravenous (IV) single dose | Placebo comparator | Drug: PlaceboAdministered as normal saline (0.9% Sodium Chloride) |
| Placebo Subcutaneous (SC) single dose | Placebo comparator | Drug: PlaceboAdministered as normal saline (0.9% Sodium Chloride) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must have given written informed consent and be able to comply with all study requirements
- Males and females aged 18-55 at the time of informed consent
- Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method
- Males must be surgically sterile, abstinent or using an acceptable contraceptive method
- The subject has a BMI of 19 to 32 kg/m^2 inclusive
Key exclusion criteria (7 listed)
- History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia
- Abnormal screening ECG
- Use of concomitant medications unless authorized by the Sponsor Medical Monitor
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- Treatment with another Study Drug, biological agent, or device within one-month of 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 |
|---|---|---|
| VolanesorsenISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial | Drug | Volanesorsen, Intravenous (IV), Volanesorsen, Subcutaneous (SQ) |
| MoxifloxacinMoxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose | Drug | Moxifloxacin Hydrochloride |
| Placebo | Drug | Placebo Intravenous (IV) single dose, Placebo Subcutaneous (SC) single dose |
Primary outcome
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)
Time frame: 24 Hours
ECG monitoring up to 24 hours post dose
1 secondary outcome
Placebo corrected change from baseline heart rate (HR, PR and QRS)
Time frame: 24 Hours
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 28 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Volanesorsen and Moxifloxacin in people with Abnormalities, Cardiovascular, run by Ionis Pharmaceuticals, 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 6 inclusion and 7 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 Jan 2022. 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?
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval) (time frame: 24 Hours). 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 28 Jan 2022.