Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500.

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

Details

• Lead Sponsor: Viriom
• Treatments: Darunavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

1. Male subjects age between 18-45 years

2. Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs

3. Has normal or acceptable results for the following screening tests: complete blood count (CBC), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood sugar (FBS), total bilirubin, aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP) and urinalysis.

4. Negative result for hepatitis A, hepatitis B, hepatitis C and HIV antibodies

5. Willing to participate and signed the informed consent form

Exclusion Criteria:

1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion of the Investigator interfere with the results of the study or threaten the health of volunteers;

2. Drug intake (including herbal drugs) during the last month;

3. Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements;

4. Volunteers have taken any investigational drug at least 3 month prior to the start of the study;

5. Inability to understand the Protocol or follow its instructions.