Expired Study
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West Bend, Wisconsin 53095


Purpose:

This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.


Criteria:

Inclusion Criteria: - Provision of written informed consent before any study-specific procedure - Good health as determined by medical history, physical examination, vital sign measurements, 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 2 years or less with a follicle-stimulating hormone assessment greater than or equal to 40 IU/L 2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose - For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL - Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18 and 40 kg/m², inclusive, for Part B, and body weight >50 kg at Screening Exclusion Criteria: - Use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing. Additionally for Part B only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing - 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 is Available At:


Original ID:

CAT-2054-101


NCT ID:

NCT02374047


Secondary ID:


Study Acronym:


Brief Title:

A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjec


Official Title:


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Catabasis Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

12


Number of Groups:

0


Total Enrollment:

118


Enrollment Type:

Actual


Study Dates

Start Date:January 2015
Completion Date:July 2015
Completion Type:Actual
Primary Completion Date:July 2015
Primary Completion Type:Actual
Verification Date:March 2016
Last Changed Date:March 21, 2016
First Received Date:February 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:AUC48 of Atorvastatin
Time Frame:up to 3 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assess the pharmacodynamic effects of multiple doses of CAT-2054 on serum lipids LDL-C, non-HDL-C, total cholesterol, triglycerides, HDL-C, apoB, and PCSK9.
Time Frame:up to 3 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes from baseline for hematology, chemistry, coagulation and urinalysis
Time Frame:up to 3 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Cmax of CAT-2054
Time Frame:up to 3 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:AUCinf of CAT-2054
Time Frame:Days 1 through 4
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Frequency and severity of adverse events
Time Frame:up to 3 weeks
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:CAT-2054
Arm Name:Cohort A1, Dose Level 1: CAT-2054 or placebo fasti
Intervention Type:Drug
Name:Placebo
Arm Name:Cohort A1, Dose Level 1: CAT-2054 or placebo fasti
Intervention Type:Drug
Name:CAT-2054-C
Arm Name:Cohort A5, Dose Level 5: CAT-2054-C or placebo fas
Intervention Type:Drug
Name:Atorvastatin
Arm Name:Cohort B6, Dose Level 6: CAT-2054 with atorvastati

Study Arms

Study Arm Type:Experimental
Arm Name:Cohort B7, Dose Level 7: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B6, Dose Level 6: CAT-2054 with atorvastatin
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B5, Dose Level 5: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B4, Dose Level 4: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B3, Dose Level 3: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B2, Dose Level 2: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort B1, Dose Level 1: CAT-2054 or placebo
Description:Multiple dose for 14 days
Study Arm Type:Experimental
Arm Name:Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed
Description:Single dose
Study Arm Type:Experimental
Arm Name:Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed
Description:Single dose
Study Arm Type:Experimental
Arm Name:Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed
Description:Single dose
Study Arm Type:Experimental
Arm Name:Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed
Description:Single dose
Study Arm Type:Experimental
Arm Name:Cohort A1, Dose Level 1: CAT-2054 or placebo fasting
Description:Single dose

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Catabasis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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