Status:
COMPLETED
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
Lead Sponsor:
Resverlogix Corp
Conditions:
Dyslipidemia
Atherosclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
Detailed Description
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The maj...
Eligibility Criteria
Inclusion
- Subjects who meet the following criteria may be enrolled:
- Be men or women between 18 and 65 years old, inclusive
- Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m2.
- Healthy volunteers with normal or low HDL
- If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.
Exclusion
- Subjects who meet any of the following criteria will not be enrolled:
- Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator.
- Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study).
- Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
- Have hypertension that is currently being treated, or uncontrolled hypertension
- Have a serum creatinine \>1.5 mg/dL, hemoglobin \<11.2 g/dL, or white blood cell count \<4000/μL.
- Have positive test results for HIV, hepatitis A, B, or C.
- Have a positive result on drug screen testing.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00768274
Start Date
September 1 2008
End Date
August 1 2009
Last Update
November 4 2022
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247