A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/30/2013 |
| Start Date: | November 2012 |
| End Date: | May 2013 |
A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects
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.
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;
We found this trial at
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