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

NCT ID: NCT00768274

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-08-31

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 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.

Conditions

Dyslipidemia; Atherosclerosis; Acute Coronary Syndrome; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A

Low-dose apabetalone (RVX000222) or placebo

Group Type: EXPERIMENTAL

RVX000222

Intervention Type: DRUG

RVX000222 twice daily (b.i.d.) for 28 days

Placebo

Intervention Type: DRUG

Placebo twice daily (b.i.d.) for 28 days

Arm B

apabetalone (RVX000222) Dose-escalation or placebo

Group Type: EXPERIMENTAL

RVX000222

Intervention Type: DRUG

RVX000222 twice daily (b.i.d.) for 28 days

Placebo

Intervention Type: DRUG

Placebo twice daily (b.i.d.) for 28 days

Arm C

high-dose apabetalone (RVX000222) or placebo

Group Type: EXPERIMENTAL

RVX000222

Intervention Type: DRUG

RVX000222 twice daily (b.i.d.) for 28 days

Placebo

Intervention Type: DRUG

Placebo twice daily (b.i.d.) for 28 days

Interventions

RVX000222

RVX000222 twice daily (b.i.d.) for 28 days

Intervention Type: DRUG

Placebo

Placebo twice daily (b.i.d.) for 28 days

Intervention Type: DRUG

Other Intervention Names

RVX-208; apabetalone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Resverlogix Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan Gordon, MD, PhD

Role: STUDY_DIRECTOR

Resverlogix Corp

Locations

Covance Clinical Research Unit, Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

RVX222-CS-003

Identifier Type: -

Identifier Source: org_study_id