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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014