Mild DyslipidemiaPhase 1NCT01105598
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
A Phase 1 study of Mild Dyslipidemia, run by Esperion Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Dyslipidemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2010to 2 Oct 2010
- 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
- Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
- Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
- Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
- Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight >50 kg
Who cannot join
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- Alanine aminotransferase (ALT) or aspartate amino transferase (AST) >1.2 x ULN; serum creatinine >ULN; hemoglobin <12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
- Use of tobacco or tobacco products
- Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin >500 mg/day or fish oil which will not have been used for 3 months prior to randomization
- Other exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
- Conditions
- Mild Dyslipidemia
- Being tested
- ETC-1002 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002 or placeboDrug
ETC-1002 (ascending dose), daily for 14 days
ETC-1002 or placeboDrug
ETC-1002 (optimized dose), daily for 28 days
ETC-1002 or placeboDrug
ETC-1002 (20 mg), daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit Receives: Drug: ETC-1002 or placebo |
| Cohort 2 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit Receives: Drug: ETC-1002 or placebo |
| Cohort 3 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit Receives: Drug: ETC-1002 or placebo |
| Cohort 4 | Experimental | Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit Receives: Drug: ETC-1002 or placebo |
| Cohort 5 | Experimental | Free-living subjects (18 active/6 placebo) with mild dyslipidemia Receives: Drug: ETC-1002 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Measured: 14 or 28 days
Secondary outcomes (1)
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)
Measured: 14 or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study start20 Apr 2010
- Primary completion2 Oct 2010
- Study completion2 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DyslipidemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim C Khalifa, MD, Study director, Esperion Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105598
- Sponsor's protocol ID
- ETC-1002-002
- Status last verified
- Mar 2019
- First submitted
- 15 Apr 2010
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ETC-1002 in Subjects With Mild Dyslipidemia
- ClinicalTrials.gov ID
- NCT01105598
- Acronym / sponsor ID
- ETC-1002-002
- Conditions
- Mild Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2010 (actual)
- Primary completion
- 2 Oct 2010 (actual)
- Study completion
- 2 Oct 2010 (actual)
- First posted
- 16 Apr 2010 (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 Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ETC-1002 or placeboSubjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
| Cohort 2 | Experimental | Drug: ETC-1002 or placeboSubjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
| Cohort 3 | Experimental | Drug: ETC-1002 or placeboSubjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
| Cohort 4 | Experimental | Drug: ETC-1002 or placeboSubjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit |
| Cohort 5 | Experimental | Drug: ETC-1002 or placeboFree-living subjects (18 active/6 placebo) with mild dyslipidemia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
- Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
- Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
- Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight >50 kg
Key exclusion criteria (5 listed)
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- Alanine aminotransferase (ALT) or aspartate amino transferase (AST) >1.2 x ULN; serum creatinine >ULN; hemoglobin <12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
- Use of tobacco or tobacco products
- Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin >500 mg/day or fish oil which will not have been used for 3 months prior to randomization
- Other exclusion criteria apply
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 |
|---|---|---|
| ETC-1002 or placeboETC-1002 (ascending dose), daily for 14 days | Drug | Cohort 2, Cohort 3, Cohort 4 |
| ETC-1002 or placeboETC-1002 (optimized dose), daily for 28 days | Drug | Cohort 5 |
| ETC-1002 or placeboETC-1002 (20 mg), daily for 14 days | Drug | Cohort 1 |
Primary outcome
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Time frame: 14 or 28 days
1 secondary outcome
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Time frame: 14 or 28 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 28 Mar 2019.
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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.
Jim C Khalifa, MD study director
Esperion Therapeutics, Inc.
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 of Mild Dyslipidemia, run by Esperion Therapeutics, 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 4 inclusion and 5 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 Mar 2019. 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?
Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values (time frame: 14 or 28 days). 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 Mar 2019.