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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:
Resverlogix Corp
ClinicalTrials.gov Identifier:
NCT00768274
First received: October 7, 2008
Last updated: January 27, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Dyslipidemia
Atherosclerosis
Acute Coronary Syndrome
Cardiovascular Disease
 Drug: RVX000222 (common name RVX-208)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Resverlogix Corp:

Primary Outcome Measures:
  • Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo. [ Time Frame: 1-month ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2008
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Treatment A
Low-dose and placebo
 Drug: RVX000222 (common name RVX-208)
RVX000222 or placebo twice daily (b.i.d.) for 28 days
Experimental: 2 Treatment B
Dose-escalation and placebo
 Drug: RVX000222 (common name RVX-208)
RVX000222 or placebo twice daily (b.i.d.) for 28 days
Experimental: 3 Treatment C
high-dose and placebo
 Drug: RVX000222 (common name RVX-208)
RVX000222 or placebo twice daily (b.i.d.) for 28 days

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768274

Locations
United States, Texas
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Resverlogix Corp
Investigators
Study Director: Allan Gordon, MD, PhD Resverlogix Corp
  More Information

No publications provided

Responsible Party: Allan Gordon, MD, PhD; Senior Vice President, Clinical Development, Resverlogix Corporation
ClinicalTrials.gov Identifier: NCT00768274     History of Changes
Other Study ID Numbers: RVX222-CS-003
Study First Received: October 7, 2008
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Resverlogix Corp:
Cholesterol
High density lipoprotein
Dyslipidemia
Atherosclerosis
Apolipoprotein A-I

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Dyslipidemias
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
 Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013