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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Single dose

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort B1: Dose level 6: CAT 2003 or placebo

Multiple dose for 14 days

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort B2: Dose level 7: CAT 2003 or placebo

Multiple dose for 14 days

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort B3: Dose level 8: CAT 2003 or placebo

Multiple dose for 14 days

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort B4: Dose level 9: CAT 2003 or placebo

Multiple dose for 14 days

Group Type EXPERIMENTAL

CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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CAT 2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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;

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes