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Completed

NCT Number: NCT01725594

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace CPU

Cincinnati, Ohio, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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;

Treatment and study plan

CAT 2003

Drug

Placebo

Drug

Primary outcomes

  1. Frequency and severity of adverse events

    Time frame: Screening to End of study (up to 4 weeks following randomization)

Secondary outcomes

  1. AUCinf of CAT-2003

    Time frame: Days 1, 7 and 14

  2. Cmax of CAT-1004

    Time frame: Days 1, 7 and14

  3. Changes from baseline for hematology, chemistry, coagulation and urinalysis

    Time frame: Baseline through End of study (up to 4 weeks)

  4. Changes from baseline for Physical exams

    Time frame: Baseline through end of study (up to 4 weeks)

  5. Changes from baseline for ECGs

    Time frame: Baseline through end of study (up to 4 weeks)

  6. Changes from baseline in vital signs

    Time frame: Baseline through end of study (up to 4 weeks)

  7. 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

    Time frame: Baseline to end of study (up to 4 weeks)

Sponsors and collaborators

Lead sponsor

Catabasis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2012
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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