A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | July 2015 |
This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple
ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)
or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single
dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a
second dose of the study drug after a high-fat meal. Additionally, at 1 dose level,
CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects
will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054
will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days.
In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to
assess safety in anticipation of future clinical trials.
ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)
or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single
dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a
second dose of the study drug after a high-fat meal. Additionally, at 1 dose level,
CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects
will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054
will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days.
In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to
assess safety in anticipation of future clinical trials.
Inclusion Criteria:
- Provision of written informed consent before any study-specific procedure
- Good health as determined by medical history, physical examination, vital sign
measurements, 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 2 years or less with a follicle-stimulating hormone
assessment greater than or equal to 40 IU/L
2. Males: surgically sterile, abstinent, or subject or partner is utilizing an
acceptable contraceptive method during and 3 months after the last study dose
- For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only)
fasting LDL-C ≥130 mg/dL
- Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18
and 40 kg/m², inclusive, for Part B, and body weight >50 kg at Screening
Exclusion Criteria:
- Use of prescription drugs or non-prescription drugs including herbals, and dietary
supplements (including multivitamins and any product containing niacin or omega-3
fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing.
Additionally for Part B only, use of any lipid-regulating prescription drug,
non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing
- 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
1
site
Click here to add this to my saved trials
