DyslipidemiaPhase 1NCT01725594
A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
A Phase 1 study testing CAT 2003 in people with Dyslipidemia, run by Catabasis Pharmaceuticals at 1 site in United States.
Trial summary
This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- CAT 2003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 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
Major Inclusion Criteria:
- Provision of written informed consent prior to any study-specific procedure;
- Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
- Satisfies one of the following:
- Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR
- Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose;
Major Exclusion Criteria:
- Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF >450;
- Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects
This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
- Conditions
- Dyslipidemia
- Being tested
- CAT 2003, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT 2003Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1, Dose Level 1: CAT 2003 or placebo fasting | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A2, Dose Level 2: CAT 2003 or placebo fasting | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A3, Dose Level 3: CAT 2003 or placebo fasting | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A4, Dose Level 4: CAT 2003 or placebo fasting | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A5, Dose Level 5: CAT 2003 or placebo fasting | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A2: Dose Level 2: CAT 2003 or placebo fed | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort A3: Dose level 3:CAT 2003 or placebo fed | Experimental | Single dose Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort B1: Dose level 6: CAT 2003 or placebo | Experimental | Multiple dose for 14 days Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort B2: Dose level 7: CAT 2003 or placebo | Experimental | Multiple dose for 14 days Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort B3: Dose level 8: CAT 2003 or placebo | Experimental | Multiple dose for 14 days Receives: Drug: CAT 2003; Drug: Placebo |
| Cohort B4: Dose level 9: CAT 2003 or placebo | Experimental | Multiple dose for 14 days Receives: Drug: CAT 2003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
Measured: Screening to End of study (up to 4 weeks following randomization)
Secondary outcomes (7)
AUCinf of CAT-2003
Measured: Days 1, 7 and 14
Cmax of CAT-1004
Measured: Days 1, 7 and14
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Measured: Baseline through End of study (up to 4 weeks)
Changes from baseline for Physical exams
Measured: Baseline through end of study (up to 4 weeks)
Changes from baseline for ECGs
Measured: Baseline through end of study (up to 4 weeks)
Changes from baseline in vital signs
Measured: Baseline through end of study (up to 4 weeks)
Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia
Measured: Baseline to end of study (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukasz Biernat, M.D, Principal investigator, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725594
- Sponsor's protocol ID
- CAT-2003-101
- Status last verified
- Jul 2013
- First submitted
- 6 Nov 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01725594
- Acronym / sponsor ID
- CAT-2003-101
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Nov 2012 (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 is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort A1, Dose Level 1: CAT 2003 or placebo fasting | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A2, Dose Level 2: CAT 2003 or placebo fasting | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A3, Dose Level 3: CAT 2003 or placebo fasting | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A4, Dose Level 4: CAT 2003 or placebo fasting | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A5, Dose Level 5: CAT 2003 or placebo fasting | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A2: Dose Level 2: CAT 2003 or placebo fed | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort A3: Dose level 3:CAT 2003 or placebo fed | Experimental | Drug: CAT 2003, Drug: PlaceboSingle dose |
| Cohort B1: Dose level 6: CAT 2003 or placebo | Experimental | Drug: CAT 2003, Drug: PlaceboMultiple dose for 14 days |
| Cohort B2: Dose level 7: CAT 2003 or placebo | Experimental | Drug: CAT 2003, Drug: PlaceboMultiple dose for 14 days |
| Cohort B3: Dose level 8: CAT 2003 or placebo | Experimental | Drug: CAT 2003, Drug: PlaceboMultiple dose for 14 days |
| Cohort B4: Dose level 9: CAT 2003 or placebo | Experimental | Drug: CAT 2003, Drug: PlaceboMultiple dose for 14 days |
Who may qualify
- Ages
- 18 to 55 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 |
|---|---|---|
| CAT 2003 | Drug | Cohort A1, Dose Level 1: CAT 2003 or placebo fasting, Cohort A2, Dose Level 2: CAT 2003 or placebo fasting, Cohort A2: Dose Level 2: CAT 2003 or placebo fed, Cohort A3, Dose Level 3: CAT 2003 or placebo fasting, Cohort A3: Dose level 3:CAT 2003 or placebo fed, Cohort A4, Dose Level 4: CAT 2003 or placebo fasting, Cohort A5, Dose Level 5: CAT 2003 or placebo fasting, Cohort B1: Dose level 6: CAT 2003 or placebo, Cohort B2: Dose level 7: CAT 2003 or placebo, Cohort B3: Dose level 8: CAT 2003 or placebo, Cohort B4: Dose level 9: CAT 2003 or placebo |
| Placebo | Drug | Cohort A1, Dose Level 1: CAT 2003 or placebo fasting, Cohort A2, Dose Level 2: CAT 2003 or placebo fasting, Cohort A2: Dose Level 2: CAT 2003 or placebo fed, Cohort A3, Dose Level 3: CAT 2003 or placebo fasting, Cohort A3: Dose level 3:CAT 2003 or placebo fed, Cohort A4, Dose Level 4: CAT 2003 or placebo fasting, Cohort A5, Dose Level 5: CAT 2003 or placebo fasting, Cohort B1: Dose level 6: CAT 2003 or placebo, Cohort B2: Dose level 7: CAT 2003 or placebo, Cohort B3: Dose level 8: CAT 2003 or placebo, Cohort B4: Dose level 9: CAT 2003 or placebo |
Primary outcome
Frequency and severity of adverse events
Time frame: Screening to End of study (up to 4 weeks following randomization)
7 secondary outcomes
AUCinf of CAT-2003
Time frame: Days 1, 7 and 14
Cmax of CAT-1004
Time frame: Days 1, 7 and14
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Time frame: Baseline through End of study (up to 4 weeks)
Changes from baseline for Physical exams
Time frame: Baseline through end of study (up to 4 weeks)
Changes from baseline for ECGs
Time frame: Baseline through end of study (up to 4 weeks)
Changes from baseline in vital signs
Time frame: Baseline through end of study (up to 4 weeks)
Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia
Time frame: Baseline to end of study (up to 4 weeks)
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 11 Jul 2013.
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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.
Lukasz Biernat, M.D principal investigator
Medpace, 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 CAT 2003 in people with Dyslipidemia, run by Catabasis Pharmaceuticals 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 11 Jul 2013. 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?
Frequency and severity of adverse events (time frame: Screening to End of study (up to 4 weeks following randomization)). 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 11 Jul 2013.