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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: CAT 2003; Drug: Placebo

• Registration Number: NCT01725594
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events	Screening to End of study (up to 4 weeks following randomization)

Secondary Outcome Measures

Name	Time	Method
AUCinf of CAT-2003	Days 1, 7 and 14
Cmax of CAT-1004	Days 1, 7 and14
Changes from baseline for hematology, chemistry, coagulation and urinalysis	Baseline through End of study (up to 4 weeks)
Changes from baseline for Physical exams	Baseline through end of study (up to 4 weeks)
Changes from baseline for ECGs	Baseline through end of study (up to 4 weeks)
Changes from baseline in vital signs	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	Baseline to end of study (up to 4 weeks)

Trial Locations

Locations (1)

Medpace CPU; 🇺🇸 Cincinnati, Ohio, United States