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

NCT02374047 | Completed Phase 1

• 1 other identifier: CAT-2054-101
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events

  up to 3 weeks

Secondary Outcomes (5)

• AUCinf of CAT-2054

  Days 1 through 4

• Cmax of CAT-2054

  up to 3 weeks

• Changes from baseline for hematology, chemistry, coagulation and urinalysis

  up to 3 weeks

• 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.

  up to 3 weeks

• AUC48 of Atorvastatin

  up to 3 weeks

Study Arms (12)

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

EXPERIMENTAL

Single dose

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Single dose

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Single dose

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Single dose

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Single dose

Drug: Placebo; Drug: CAT-2054-C

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Atorvastatin

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

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT-2054; Drug: Placebo

Interventions

CAT-2054 DRUG

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 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

Placebo DRUG

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 B7, Dose Level 7: CAT-2054 or placebo

CAT-2054-C DRUG

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

Atorvastatin DRUG

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catabasis Pharmaceuticals: lead

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 27, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (1)