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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374047
• Other study ID #: CAT-2054-101
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: January 2021
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• CAT-2054

• Placebo

• CAT-2054-C

• Atorvastatin

Locations

Country	Name	City	State
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events		up to 3 weeks
Secondary	AUCinf of CAT-2054		Days 1 through 4
Secondary	Cmax of CAT-2054		up to 3 weeks
Secondary	Changes from baseline for hematology, chemistry, coagulation and urinalysis		up to 3 weeks
Secondary	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
Secondary	AUC48 of Atorvastatin		up to 3 weeks