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

NCT02489487 | Completed Phase 1

• 1 other identifier: VM-1500-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-infection

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by Division of AIDS table for grading the severity of ADULT Adverse Events

  Safety and tolerability of VM-1500 alone or in combination with raltegravir or darunavir in adult healthy subjects

  36 days

Secondary Outcomes (2)

• Plasma concentrations of VM-1500 from Day 1 to Day 36

  36 days

• Plasma concentrations of VM1500A (active metabolite of VM1500) from Day 1 to Day 36

  36 days

Study Arms (3)

VM-1500 + Raltegravir

EXPERIMENTAL

VM-1500 40 mg in combination with 400 mg Raltegravir

Drug: VM-1500; Drug: Raltegravir

VM-1500 +Darunavir

EXPERIMENTAL

VM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir

Drug: VM-1500; Drug: Darunavir; Drug: Ritonavir

VM-1500

EXPERIMENTAL

VM-1500 40 mg alone

Drug: VM-1500

Interventions

VM-1500 DRUG

VM-1500 40 mg

VM-1500; VM-1500 + Raltegravir; VM-1500 +Darunavir

Darunavir DRUG

Darunavir 600 mg

VM-1500 +Darunavir

Ritonavir DRUG

Ritonavir 100 mg

VM-1500 +Darunavir

Raltegravir DRUG

400 mg Raltegravir

VM-1500 + Raltegravir

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects age between 18-45 years
• Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
• 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.
• Negative result for hepatitis A, hepatitis B, hepatitis C and HIV antibodies
• Willing to participate and signed the informed consent form

You may not qualify if:

• 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;
• Drug intake (including herbal drugs) during the last month;
• Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements;
• Volunteers have taken any investigational drug at least 3 month prior to the start of the study;
• Inability to understand the Protocol or follow its instructions.

Sponsors & Collaborators

• Viriom: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital

Bangkok, Wanglang Road, 10700, Thailand

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir; Ritonavir; Raltegravir Potassium

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Pyrrolidinones; Pyrrolidines

Study Officials

• Somruedee Chatsiricharoenkul, MD

  Acriles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 3, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)