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

NCT00768274 | Completed Phase 1

• 1 other identifier: RVX222-CS-003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemia; Atherosclerosis; Acute Coronary Syndrome; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1-month

Study Arms (3)

Arm A

EXPERIMENTAL

Low-dose apabetalone (RVX000222) or placebo

Drug: RVX000222; Drug: Placebo

Arm B

EXPERIMENTAL

apabetalone (RVX000222) Dose-escalation or placebo

Drug: RVX000222; Drug: Placebo

Arm C

EXPERIMENTAL

high-dose apabetalone (RVX000222) or placebo

Drug: RVX000222; Drug: Placebo

Interventions

RVX000222 DRUG

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

Also known as: RVX-208, apabetalone

Arm A; Arm B; Arm C

Placebo DRUG

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

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Resverlogix Corp: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Atherosclerosis; Acute Coronary Syndrome; Cardiovascular Diseases

Interventions

apabetalone

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Allan Gordon, MD, PhD

  Resverlogix Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 4, 2022

Record last verified: 2016-07

Locations

US (1)