Elevated Lipoprotein(a)Phase 1NCT03426033
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
A Phase 1 study testing ISIS 681257 and Warfarin in people with Elevated Lipoprotein(a) and Cardiovascular Diseases, run by Akcea Therapeutics at 1 site in Canada.
Trial summary
This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Lipoprotein(a), Cardiovascular Diseases
- What is being tested?
- ISIS 681257 and Warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2017to 25 Feb 2018
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Motivated and available for duration of study and willing to adhere to protocol
- Males who are unable to procreate or agree to contraception throughout study
- Females who are postmenopausal or surgically sterile
- BMI between 18.5 and 30 kg/m2
- Weighing greater than or equal to 50kg
- Normal lab results
- No known diseases or significant findings on physical exam
Who cannot join
- Females of childbearing potential
- Reactions/infection at injection site
- Hypersensitivity to any drugs or similar drugs to those used in the study
- Conditions or disease that may interfere with study drug
- Any significant diseases
- Known history or familial history of bleeding disorders
Show all 10Show fewer
- Drug dependency or abuse
- Illness within 28 days
- Previous exposure to other investigational drug within 28 days
- Blood donations within 28 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
- Conditions
- Elevated Lipoprotein(a), Cardiovascular Diseases
- Being tested
- ISIS 681257, Warfarin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 681257Drug
Xmg dose administered as a subcutaneous injection
WarfarinDrug
25mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Single dose of warfarin | Experimental | Single dose of warfarin administered to obtain pharmacokinetic information. Receives: Drug: Warfarin |
| Warfarin in combination with ISIS 681257 | Experimental | ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained. Receives: Drug: ISIS 681257; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.
Measured: Each day for days 1-10 and 15-45
Secondary outcomes (5)
The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.
To evaluate the safety and tolerability of multiple doses of ISIS 681257 40 mg subcutaneous injections when coadministered with a single oral dose of warfarin in healthy adult subjects.
Measured: 45 days
Prothrombin Time will be measured by testing blood samples at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Measured: Each day for days 1-7 and 15-21
International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Measured: Each day for days 1-7 and 15-21
Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (anticoagulant activity) of a single oral dose of warfarin in healthy adult subjects.
Measured: Each day for days 1-7 and 15-21
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
To evaluate the effect of a single dose of warfarin on the pharmacokinetics of a single subcutaneous 40 mg injection of ISIS 681257 in healthy adult subjects.
Measured: Each day for days 1-10 and 15-45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Dec 2017
- Primary completion25 Feb 2018
- Study completion25 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Lipoprotein(a)Studies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akcea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426033
- Sponsor's protocol ID
- ISIS 681257-CS10
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.
PubMed 37070852
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
- ClinicalTrials.gov ID
- NCT03426033
- Acronym / sponsor ID
- ISIS 681257-CS10
- Conditions
- Elevated Lipoprotein(a), Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Akcea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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 single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of warfarin | Experimental | Drug: WarfarinSingle dose of warfarin administered to obtain pharmacokinetic information. |
| Warfarin in combination with ISIS 681257 | Experimental | Drug: ISIS 681257, Drug: WarfarinISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Motivated and available for duration of study and willing to adhere to protocol
- Males who are unable to procreate or agree to contraception throughout study
- Females who are postmenopausal or surgically sterile
- BMI between 18.5 and 30 kg/m2
- Weighing greater than or equal to 50kg
Key exclusion criteria (10 listed)
- Females of childbearing potential
- Reactions/infection at injection site
- Hypersensitivity to any drugs or similar drugs to those used in the study
- Conditions or disease that may interfere with study drug
- Any significant diseases
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 |
|---|---|---|
| ISIS 681257Xmg dose administered as a subcutaneous injection | Drug | Warfarin in combination with ISIS 681257 |
| Warfarin25mg tablet administered orally | Drug | Single dose of warfarin, Warfarin in combination with ISIS 681257 |
Primary outcome
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
Time frame: Each day for days 1-10 and 15-45
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.
5 secondary outcomes
The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.
Time frame: 45 days
Prothrombin Time will be measured by testing blood samples at each individual time point.
Time frame: Each day for days 1-7 and 15-21
International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.
Time frame: Each day for days 1-7 and 15-21
Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.
Time frame: Each day for days 1-7 and 15-21
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
Time frame: Each day for days 1-10 and 15-45
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 5 Apr 2018.
- Derived from this study: PubMed 37070852Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.
- Individual participant dataSharing planned: No
Related trials for Elevated Lipoprotein(a)
RecruitingPhase 2
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
Lipoprotein(a)
Recruiting
Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?
ASCVD, LDL-C
Active, not recruitingPhase 2
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Lipoprotein Disorder
Active, not recruitingPhase 2
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
Hypercholesterolemia
Active, not recruitingPhase 3
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Atherosclerotic Cardiovascular Disease (ASCVD)
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 ISIS 681257 and Warfarin in people with Elevated Lipoprotein(a) and Cardiovascular Diseases, run by Akcea Therapeutics at 1 site in Canada.
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 7 inclusion and 10 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 5 Apr 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 Canada. 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 plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point. (time frame: Each day for days 1-10 and 15-45). 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 NCT03426033, 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 5 Apr 2018.