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

Primary Purpose

Dyslipidemia, Atherosclerosis, Acute Coronary Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RVX000222

Placebo

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Cholesterol, High density lipoprotein, Dyslipidemia, Atherosclerosis, Apolipoprotein A-I

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Covance Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Low-dose apabetalone (RVX000222) or placebo

apabetalone (RVX000222) Dose-escalation or placebo

high-dose apabetalone (RVX000222) or placebo

Outcomes

Primary Outcome Measures

Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.

Secondary Outcome Measures

Full Information

NCT ID

NCT00768274

First Posted

October 7, 2008

Last Updated

November 1, 2022

Sponsor

Resverlogix Corp

1. Study Identification

Unique Protocol Identification Number

NCT00768274

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Resverlogix Corp

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia, Atherosclerosis, Acute Coronary Syndrome, Cardiovascular Disease

Keywords

Cholesterol, High density lipoprotein, Dyslipidemia, Atherosclerosis, Apolipoprotein A-I

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Low-dose apabetalone (RVX000222) or placebo

Arm Title

Arm B

Arm Type

Experimental

Arm Description

apabetalone (RVX000222) Dose-escalation or placebo

Arm Title

Arm C

Arm Type

Experimental

Arm Description

high-dose apabetalone (RVX000222) or placebo

Intervention Type

Drug

Intervention Name(s)

RVX000222

Other Intervention Name(s)

RVX-208, apabetalone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.

Time Frame

1-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan Gordon, MD, PhD

Organizational Affiliation

Resverlogix Corp

Official's Role

Study Director

Facility Information:

Facility Name

Covance Clinical Research Unit, Inc.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

12. IPD Sharing Statement

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

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