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A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003

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ClinicalTrials.gov Identifier: NCT01725594
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals

Brief 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. In Part B, CAT-2003 is administered for 14 consecutive days.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: CAT 2003 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A2: Dose Level 2: CAT 2003 or placebo fed
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort A3: Dose level 3:CAT 2003 or placebo fed
Single dose
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort B1: Dose level 6: CAT 2003 or placebo
Multiple dose for 14 days
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort B2: Dose level 7: CAT 2003 or placebo
Multiple dose for 14 days
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort B3: Dose level 8: CAT 2003 or placebo
Multiple dose for 14 days
Drug: CAT 2003
Drug: Placebo
Experimental: Cohort B4: Dose level 9: CAT 2003 or placebo
Multiple dose for 14 days
Drug: CAT 2003
Drug: Placebo



Primary Outcome Measures :
  1. Frequency and severity of adverse events [ Time Frame: Screening to End of study (up to 4 weeks following randomization) ]

Secondary Outcome Measures :
  1. AUCinf of CAT-2003 [ Time Frame: Days 1, 7 and 14 ]
  2. Cmax of CAT-1004 [ Time Frame: Days 1, 7 and14 ]
  3. Changes from baseline for hematology, chemistry, coagulation and urinalysis [ Time Frame: Baseline through End of study (up to 4 weeks) ]
  4. Changes from baseline for Physical exams [ Time Frame: Baseline through end of study (up to 4 weeks) ]
  5. Changes from baseline for ECGs [ Time Frame: Baseline through end of study (up to 4 weeks) ]
  6. Changes from baseline in vital signs [ Time Frame: Baseline through end of study (up to 4 weeks) ]
  7. 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) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. 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
    2. 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725594


Locations
United States, Ohio
Medpace CPU
Cincinnati, Ohio, United States
Sponsors and Collaborators
Catabasis Pharmaceuticals
Investigators
Principal Investigator: Lukasz Biernat, M.D Medpace, Inc.

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01725594     History of Changes
Other Study ID Numbers: CAT-2003-101
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases