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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Resverlogix Corp

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.