Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Dyslipidemia, Atherosclerosis, Acute Coronary Syndrome, Cardiovascular Disease
In brief
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
Key facts
- Study ID
- NCT00768274
- Run by
- Resverlogix Corp
- People needed
- 72
- Starts
- 2008-09-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2022-11-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Covance Clinical Research Unit, Inc. — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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