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Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Resverlogix Corp
ClinicalTrials.gov Identifier:
NCT00768274
First received: October 7, 2008
Last updated: October 28, 2013
Last verified: October 2013

October 7, 2008
October 28, 2013
September 2008
August 2009   (final data collection date for primary outcome measure)
Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo. [ Time Frame: 1-month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768274 on ClinicalTrials.gov Archive Site
Not Provided
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Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)

The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.

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 major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).

HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.

RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyslipidemia
  • Atherosclerosis
  • Acute Coronary Syndrome
  • Cardiovascular Disease
Drug: RVX000222 (common name RVX-208)
RVX000222 or placebo twice daily (b.i.d.) for 28 days
  • Experimental: Arm A
    Low-dose and placebo
    Intervention: Drug: RVX000222 (common name RVX-208)
  • Experimental: Arm B
    Dose-escalation and placebo
    Intervention: Drug: RVX000222 (common name RVX-208)
  • Experimental: Arm C
    high-dose and placebo
    Intervention: Drug: RVX000222 (common name RVX-208)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Not Provided
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who meet the following criteria may be enrolled:

    1. Be men or women between 18 and 65 years old, inclusive
    2. Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m2.
    3. Healthy volunteers with normal or low HDL
    4. 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 Criteria:

  • Subjects who meet any of the following criteria will not be enrolled:

    1. 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.
    2. 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).
    3. Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
    4. Have hypertension that is currently being treated, or uncontrolled hypertension
    5. Have a serum creatinine >1.5 mg/dL, hemoglobin <11.2 g/dL, or white blood cell count <4000/μL.
    6. Have positive test results for HIV, hepatitis A, B, or C.
    7. Have a positive result on drug screen testing.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768274
RVX222-CS-003
Not Provided
Resverlogix Corp
Resverlogix Corp
Not Provided
Study Director: Allan Gordon, MD, PhD Resverlogix Corp
Resverlogix Corp
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP