A Phase 1 interventional study of ISIS 681257 and Clopidogrel in Elevated Lipoprotein(a) and Cardiovascular Diseases, sponsored by Akcea Therapeutics. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Akcea Therapeutics (part of Ionis Pharmaceuticals, Inc.) · Phase 1, Interventional, and Other
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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 multiple doses of clopidogrel
5,370 studies on the registry are indexed under Cardiovascular Diseases; 940 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Akcea Therapeutics is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiple doses of Clopidogrel to obtain pharmacokinetic information.
Drug: Clopidogrel
Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.
Drug: ISIS 681257 · Drug: Clopidogrel
Xmg dose administered as a subcutaneous injection
75mg tablet administered orally
Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects
The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.
Time frame: 55 days
Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects
Safety will be assessed by summarizing the reported adverse events
Time frame: 55 days
Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects
P2Y12 reaction units (PRUs) will be measured at each individual time point.
Time frame: 55 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Mar 2018, 2 months.
Of 53 industry-sponsored phase 1 interventional studies under Cardiovascular Diseases, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 15. This study's 2 months is below that.
Counting every sponsor, half of 96 studies reached it within 15 months; a quarter within 3 and three quarters within 45.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pelacarsen sodium · Clopidogrel