A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT02374047
- Lead Sponsor
- Catabasis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
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Provision of written informed consent before any study-specific procedure
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Good health as determined by medical history, physical examination, vital sign measurements, ECG, and clinical laboratory measurements
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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
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For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL
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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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed Placebo Single dose Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed CAT-2054-C Single dose Cohort B1, Dose Level 1: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days Cohort B1, Dose Level 1: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort B3, Dose Level 3: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort B4, Dose Level 4: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days Cohort B4, Dose Level 4: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort A1, Dose Level 1: CAT-2054 or placebo fasting CAT-2054 Single dose Cohort A1, Dose Level 1: CAT-2054 or placebo fasting Placebo Single dose Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed CAT-2054 Single dose Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed Placebo Single dose Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed CAT-2054 Single dose Cohort B2, Dose Level 2: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days Cohort B2, Dose Level 2: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed CAT-2054 Single dose Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed Placebo Single dose Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed Placebo Single dose Cohort B5, Dose Level 5: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days Cohort B5, Dose Level 5: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort B6, Dose Level 6: CAT-2054 with atorvastatin CAT-2054 Multiple dose for 14 days Cohort B6, Dose Level 6: CAT-2054 with atorvastatin Atorvastatin Multiple dose for 14 days Cohort B7, Dose Level 7: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days Cohort B7, Dose Level 7: CAT-2054 or placebo Placebo Multiple dose for 14 days Cohort B3, Dose Level 3: CAT-2054 or placebo CAT-2054 Multiple dose for 14 days
- Primary Outcome Measures
Name Time Method Frequency and severity of adverse events up to 3 weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline for hematology, chemistry, coagulation and urinalysis up to 3 weeks AUCinf of CAT-2054 Days 1 through 4 Cmax of CAT-2054 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
Trial Locations
- Locations (1)
Spaulding Clinical Research
🇺🇸West Bend, Wisconsin, United States