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

November 6, 2012
July 9, 2013
November 2012
May 2013   (final data collection date for primary outcome measure)
Frequency and severity of adverse events [ Time Frame: Screening to End of study (up to 4 weeks following randomization) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01725594 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Dyslipidemia
  • Drug: CAT 2003
  • Drug: Placebo
  • Experimental: Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A2: Dose Level 2: CAT 2003 or placebo fed
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort A3: Dose level 3:CAT 2003 or placebo fed
    Single dose
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort B1: Dose level 6: CAT 2003 or placebo
    Multiple dose for 14 days
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort B2: Dose level 7: CAT 2003 or placebo
    Multiple dose for 14 days
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort B3: Dose level 8: CAT 2003 or placebo
    Multiple dose for 14 days
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
  • Experimental: Cohort B4: Dose level 9: CAT 2003 or placebo
    Multiple dose for 14 days
    Interventions:
    • Drug: CAT 2003
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
May 2013
May 2013   (final data collection date for primary outcome measure)

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;
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01725594
CAT-2003-101
No
Catabasis Pharmaceuticals
Catabasis Pharmaceuticals
Not Provided
Principal Investigator: Lukasz Biernat, M.D Medpace, Inc.
Catabasis Pharmaceuticals
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP