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

NCT01725594 | Completed Phase 1

• 1 other identifier: CAT-2003-101
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events

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

Secondary Outcomes (7)

• AUCinf of CAT-2003

  Days 1, 7 and 14

• Cmax of CAT-1004

  Days 1, 7 and14

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

  Baseline through End of study (up to 4 weeks)

• Changes from baseline for Physical exams

  Baseline through end of study (up to 4 weeks)

• Changes from baseline for ECGs

  Baseline through end of study (up to 4 weeks)

Study Arms (11)

Cohort A1, Dose Level 1: CAT 2003 or placebo fasting

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A2, Dose Level 2: CAT 2003 or placebo fasting

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A3, Dose Level 3: CAT 2003 or placebo fasting

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A4, Dose Level 4: CAT 2003 or placebo fasting

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A5, Dose Level 5: CAT 2003 or placebo fasting

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A2: Dose Level 2: CAT 2003 or placebo fed

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort A3: Dose level 3:CAT 2003 or placebo fed

EXPERIMENTAL

Single dose

Drug: CAT 2003; Drug: Placebo

Cohort B1: Dose level 6: CAT 2003 or placebo

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT 2003; Drug: Placebo

Cohort B2: Dose level 7: CAT 2003 or placebo

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT 2003; Drug: Placebo

Cohort B3: Dose level 8: CAT 2003 or placebo

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT 2003; Drug: Placebo

Cohort B4: Dose level 9: CAT 2003 or placebo

EXPERIMENTAL

Multiple dose for 14 days

Drug: CAT 2003; Drug: Placebo

Interventions

CAT 2003 DRUG

Cohort A1, Dose Level 1: CAT 2003 or placebo fasting; Cohort A2, Dose Level 2: CAT 2003 or placebo fasting; Cohort A2: Dose Level 2: CAT 2003 or placebo fed; Cohort A3, Dose Level 3: CAT 2003 or placebo fasting; Cohort A3: Dose level 3:CAT 2003 or placebo fed; Cohort A4, Dose Level 4: CAT 2003 or placebo fasting; Cohort A5, Dose Level 5: CAT 2003 or placebo fasting; Cohort B1: Dose level 6: CAT 2003 or placebo; Cohort B2: Dose level 7: CAT 2003 or placebo; Cohort B3: Dose level 8: CAT 2003 or placebo; Cohort B4: Dose level 9: CAT 2003 or placebo

Placebo DRUG

Cohort A1, Dose Level 1: CAT 2003 or placebo fasting; Cohort A2, Dose Level 2: CAT 2003 or placebo fasting; Cohort A2: Dose Level 2: CAT 2003 or placebo fed; Cohort A3, Dose Level 3: CAT 2003 or placebo fasting; Cohort A3: Dose level 3:CAT 2003 or placebo fed; Cohort A4, Dose Level 4: CAT 2003 or placebo fasting; Cohort A5, Dose Level 5: CAT 2003 or placebo fasting; Cohort B1: Dose level 6: CAT 2003 or placebo; Cohort B2: Dose level 7: CAT 2003 or placebo; Cohort B3: Dose level 8: CAT 2003 or placebo; Cohort B4: Dose level 9: CAT 2003 or placebo

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 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;

You may not qualify if:

• 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)

Medpace CPU

Cincinnati, Ohio, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lukasz Biernat, M.D

  Medpace, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)