A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003

Dyslipidemia Clinical Trial

Official title:

A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725594
• Other study ID #: CAT-2003-101
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2012
• Last updated: July 9, 2013
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Major Inclusion Criteria:

• Provision of written informed consent prior to any study-specific procedure;

• Good health as determined by medical history, physical examination, vital signs, 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 for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR

2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose;

Major Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• CAT 2003

• Placebo

Locations

Country	Name	City	State
United States	Medpace CPU	Cincinnati	Ohio

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		Screening to End of study (up to 4 weeks following randomization)	Yes
Secondary	AUCinf of CAT-2003		Days 1, 7 and 14	No
Secondary	Cmax of CAT-1004		Days 1, 7 and14	No
Secondary	Changes from baseline for hematology, chemistry, coagulation and urinalysis		Baseline through End of study (up to 4 weeks)	Yes
Secondary	Changes from baseline for Physical exams		Baseline through end of study (up to 4 weeks)	Yes
Secondary	Changes from baseline for ECGs		Baseline through end of study (up to 4 weeks)	Yes
Secondary	Changes from baseline in vital signs		Baseline through end of study (up to 4 weeks)	Yes
Secondary	Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia		Baseline to end of study (up to 4 weeks)	No