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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CAT-2054

Placebo

CAT-2054-C

Atorvastatin

About this trial

This is an interventional other trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Spaulding Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

Cohort A1, Dose Level 1: CAT-2054 or placebo fasting

Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed

Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed

Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed

Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed

Cohort B1, Dose Level 1: CAT-2054 or placebo

Cohort B2, Dose Level 2: CAT-2054 or placebo

Cohort B3, Dose Level 3: CAT-2054 or placebo

Cohort B4, Dose Level 4: CAT-2054 or placebo

Cohort B5, Dose Level 5: CAT-2054 or placebo

Cohort B6, Dose Level 6: CAT-2054 with atorvastatin

Cohort B7, Dose Level 7: CAT-2054 or placebo

Arm Description

Single dose

Multiple dose for 14 days

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events

Secondary Outcome Measures

AUCinf of CAT-2054

Cmax of CAT-2054

Changes from baseline for hematology, chemistry, coagulation and urinalysis

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.

AUC48 of Atorvastatin

Full Information

NCT ID

NCT02374047

First Posted

February 2, 2015

Last Updated

January 27, 2021

Sponsor

Catabasis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02374047

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 Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catabasis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A1, Dose Level 1: CAT-2054 or placebo fasting

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Cohort B1, Dose Level 1: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B2, Dose Level 2: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B3, Dose Level 3: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B4, Dose Level 4: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B5, Dose Level 5: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B6, Dose Level 6: CAT-2054 with atorvastatin

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Arm Title

Cohort B7, Dose Level 7: CAT-2054 or placebo

Arm Type

Experimental

Arm Description

Multiple dose for 14 days

Intervention Type

Drug

Intervention Name(s)

CAT-2054

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

CAT-2054-C

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Primary Outcome Measure Information:

Title

Frequency and severity of adverse events

Time Frame

up to 3 weeks

Secondary Outcome Measure Information:

Title

AUCinf of CAT-2054

Time Frame

Days 1 through 4

Title

Cmax of CAT-2054

Time Frame

up to 3 weeks

Title

Changes from baseline for hematology, chemistry, coagulation and urinalysis

Time Frame

up to 3 weeks

Title

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

Title

AUC48 of Atorvastatin

Time Frame

up to 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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: 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 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

Facility Information:

Facility Name

Spaulding Clinical Research

City

West Bend

State/Province

Wisconsin

ZIP/Postal Code

53095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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