HypertriglyceridemiaPhase 1ECLIPSEIIINCT02859129
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
A Phase 1 study testing rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules) and Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose in people with Hypertriglyceridemia, run by AstraZeneca at 1 site in United States.
Trial summary
This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules) and Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2013
- 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
- Male or female (non-childbearing potential)
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
- Non-smoker
- Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs
Who cannot join
- mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
- History or presence of myopathy and/or hypothyroidism.
- History or presence of transaminase elevations
- History or presence of hypersensitivity or idiosyncratic reaction to rosuvastatin, to other HMG-CoA reductase inhibitors, to Epanova™, to Vascepa®, or to related compounds
- Known sensitivity or allergy to soybeans, fish, and/or shellfish.
- Has consumed fish within 7 days prior to check-in.
Show all 13Show fewer
- Female subjects who are pregnant or lactating.
- Positive urine drug and alcohol results at screening or check-in.
- Positive urine cotinine at screening and check-in
- Use of any drugs known to be inducers of CYP enzymes and/or P-gp
- Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
- Plasma donation within 7 days prior to the first dose of study medication.
- Participation in another clinical trial within 28 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple Doses of Epanova™ and Vascepa® in Healthy Normal Subjects
This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin
Read the detailed description
The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin. A single dose administration for rosuvastatin has been judged sufficient to yield plasma concentrations that will be detectable with an adequate validated analytical method and characterize adequately the PK of rosuvastatin.
- Conditions
- Hypertriglyceridemia
- Being tested
- rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules), Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose, Multiple (20) oral doses of 2 g Vascepa® every 12 hours
- Keywords
- Epanova, omega-3 carboxylic acids, Vascepa, Eicosapentaenoic acid ethyl ester, Crestor, rosuvastatin
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatin 40 mg tabletDrug
Also called Crestor
Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1).
Epanova™ QD (2 x 1 g capsules)Drug
Also called omega-3 carboxylic acids
Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13)
Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg doseDrug
Also called omega-3 carboxylic acids, Crestor
Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24
Multiple (20) oral doses of 2 g Vascepa® every 12 hoursDrug
Also called icosapent ethyl
Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20).
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). Receives: Drug: rosuvastatin 40 mg tablet |
| Epanova® | Experimental | Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) Receives: Drug: Epanova™ QD (2 x 1 g capsules) |
| Epanova® + Crestor® | Experimental | Epanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 Receives: Drug: Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose |
| Vascepa® | Active comparator | Vascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). Receives: Drug: Multiple (20) oral doses of 2 g Vascepa® every 12 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
ln-transformed Cmax,ss of baseline-adjusted total EPA, total DHA, and total EPA+DHA
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
Measured: Days 1 and 24
ln-transformed AUC0-tau of baseline-adjusted total EPA, total DHA, and total EPA+DHA
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
Measured: Days 1 and 24
Secondary outcomes (3)
ln-transformed Cmax,ss of unadjusted total EPA, total DHA, and total EPA+DHA
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
Measured: Days 1 and 24
dose proportionality of baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure will be assessed following multiple doses of Epanova™ 2 g and 4 g
In Cohort 1 only, dose proportionality of baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure will be assessed following multiple doses of Epanova™ 2 g and 4 g using an analysis of variance (ANOVA) on dose normalized data.
Measured: Days 1 and 24
ln-transformed AUC0-tau of unadjusted total EPA, total DHA, and total EPA+DHA
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
Measured: Days 1 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Davidson, MD, Study director, Omthera Pharmaceuticals/AstraZenecaSandra M Connolly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859129
- Sponsor's protocol ID
- OM-EPA-009
- Acronym
- ECLIPSEIII
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple Doses of Epanova™ and Vascepa® in Healthy Normal Subjects
- ClinicalTrials.gov ID
- NCT02859129
- Acronym / sponsor ID
- ECLIPSEIII / OM-EPA-009
- Conditions
- Hypertriglyceridemia
- Keywords
- Epanova, omega-3 carboxylic acids, Vascepa, Eicosapentaenoic acid ethyl ester, Crestor, rosuvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Aug 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.
This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin
Detailed description
The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin. A single dose administration for rosuvastatin has been judged sufficient to yield plasma concentrations that will be detectable with an adequate validated analytical method and characterize adequately the PK of rosuvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: rosuvastatin 40 mg tabletSingle oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). |
| Epanova® | Experimental | Drug: Epanova™ QD (2 x 1 g capsules)Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) |
| Epanova® + Crestor® | Experimental | Drug: Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg doseEpanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 |
| Vascepa® | Active comparator | Drug: Multiple (20) oral doses of 2 g Vascepa® every 12 hoursVascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female (non-childbearing potential)
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
- Non-smoker
- Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs
Key exclusion criteria (13 listed)
- mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
- History or presence of myopathy and/or hypothyroidism.
- History or presence of transaminase elevations
- History or presence of hypersensitivity or idiosyncratic reaction to rosuvastatin, to other HMG-CoA reductase inhibitors, to Epanova™, to Vascepa®, or to related compounds
- Known sensitivity or allergy to soybeans, fish, and/or shellfish.
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 |
|---|---|---|
| rosuvastatin 40 mg tabletAlso: CrestorSingle oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). | Drug | Rosuvastatin |
| Epanova™ QD (2 x 1 g capsules)Also: omega-3 carboxylic acidsMultiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13) | Drug | Epanova® |
| Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg doseAlso: omega-3 carboxylic acids, CrestorMultiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24 | Drug | Epanova® + Crestor® |
| Multiple (20) oral doses of 2 g Vascepa® every 12 hoursAlso: icosapent ethylMultiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20). | Drug | Vascepa® |
Primary outcome
ln-transformed Cmax,ss of baseline-adjusted total EPA, total DHA, and total EPA+DHA
Time frame: Days 1 and 24
ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
ln-transformed AUC0-tau of baseline-adjusted total EPA, total DHA, and total EPA+DHA
Time frame: Days 1 and 24
ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.
3 secondary outcomes
ln-transformed Cmax,ss of unadjusted total EPA, total DHA, and total EPA+DHA
Time frame: Days 1 and 24
dose proportionality of baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure will be assessed following multiple doses of Epanova™ 2 g and 4 g
Time frame: Days 1 and 24
ln-transformed AUC0-tau of unadjusted total EPA, total DHA, and total EPA+DHA
Time frame: Days 1 and 24
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 17 Aug 2016.
- CSR SynopsisLink provided by the sponsor.
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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.
Michael D Davidson, MD study director
Omthera Pharmaceuticals/AstraZeneca
Sandra M Connolly, MD principal investigator
Celerion
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 rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules) and Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose in people with Hypertriglyceridemia, run by AstraZeneca 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 4 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 17 Aug 2016. 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. 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?
ln-transformed Cmax,ss of baseline-adjusted total EPA, total DHA, and total EPA+DHA (time frame: Days 1 and 24). 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 17 Aug 2016.