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

Cardiovascular Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768274
• Other study ID #: RVX222-CS-003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2016
• Source: Resverlogix Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• RVX000222
RVX000222 twice daily (b.i.d.) for 28 days
• Placebo
Placebo twice daily (b.i.d.) for 28 days

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Resverlogix Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.		1-month