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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01725594
First received: November 6, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Dyslipidemia
Drug: CAT 2003
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Screening to End of study (up to 4 weeks following randomization) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUCinf of CAT-2003 [ Time Frame: Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Cmax of CAT-1004 [ Time Frame: Days 1, 7 and14 ] [ Designated as safety issue: No ]
  • Changes from baseline for hematology, chemistry, coagulation and urinalysis [ Time Frame: Baseline through End of study (up to 4 weeks) ] [ Designated as safety issue: Yes ]
  • Changes from baseline for Physical exams [ Time Frame: Baseline through end of study (up to 4 weeks) ] [ Designated as safety issue: Yes ]
  • Changes from baseline for ECGs [ Time Frame: Baseline through end of study (up to 4 weeks) ] [ Designated as safety issue: Yes ]
  • Changes from baseline in vital signs [ Time Frame: Baseline through end of study (up to 4 weeks) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01725594     History of Changes
Other Study ID Numbers: CAT-2003-101
Study First Received: November 6, 2012
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014