Safety Evaluation of Escalating DosesPhase 1NCT01485146
A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects
A Phase 1 study testing ETC-1002 in people with Safety Evaluation of Escalating Doses, run by Esperion Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Evaluation of Escalating Doses
- What is being tested?
- ETC-1002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2011to 25 Jan 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Major Inclusion Criteria:
- Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
- Body Mass Index of 18-32 kg/m2 inclusive with body weight >50 kg
Major Exclusion Criteria:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2 x Upper Limit of Normal(ULN), serum creatinine >ULN, Hemoglobin <12.0 g/dL
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
- Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days 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 and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.
- Conditions
- Safety Evaluation of Escalating Doses
- Being tested
- ETC-1002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002Drug
escalating doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 8 Healthy Subjects in Phase I Unit Receives: Drug: ETC-1002 |
| Cohort 2 | Experimental | 8 Healthy Subjects in Phase I Unit Receives: Drug: ETC-1002 |
| Cohort 3 | Experimental | 8 Healthy Subjects in Phase I Unit Receives: Drug: ETC-1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
Measured: 14 days
Secondary outcomes (1)
Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start25 Oct 2011
- Primary completion25 Jan 2012
- Study completion25 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety Evaluation of Escalating DosesStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Narendra Lalwani, PhD, Study director, Esperion Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485146
- Sponsor's protocol ID
- ETC-1002-004
- Status last verified
- Mar 2019
- First submitted
- 25 Oct 2011
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01485146
- Acronym / sponsor ID
- ETC-1002-004
- Conditions
- Safety Evaluation of Escalating Doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2011 (actual)
- Primary completion
- 25 Jan 2012 (actual)
- Study completion
- 25 Jan 2012 (actual)
- First posted
- 5 Dec 2011 (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), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ETC-10028 Healthy Subjects in Phase I Unit |
| Cohort 2 | Experimental | Drug: ETC-10028 Healthy Subjects in Phase I Unit |
| Cohort 3 | Experimental | Drug: ETC-10028 Healthy Subjects in Phase I Unit |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-1002escalating doses | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
Time frame: 14 days
1 secondary outcome
Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.
Time frame: 14 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.
Narendra Lalwani, PhD 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 testing ETC-1002 in people with Safety Evaluation of Escalating Doses, 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?
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?
Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. (time frame: 14 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.