Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
Information provided by (Responsible Party)
First received: June 18, 2015
Last updated: June 30, 2015
Last Verified: June 2015
History of Changes
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.
Drug : VM-1500
Drug : Darunavir
Drug : Ritonavir
Drug : Raltegravir
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I, Drug-drug Interaction Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500 When Administered Orally, in Combination With Raltegravir or Darunavir|
Further study details as provided by Viriom:
Primary Outcome Measures
- Safety and tolerability of VM-1500 alone and in combination with Raltegravir or Darunavir in adult healthy subjects based on analysis of adverse events, laboratory values. [ Time Frame: one and half month ]
- Plasma concentrations of VM-1500, given alone or in combination with Raltegravir or Darunavir. [ Time Frame: one and half month ]
|Study Start Date:||September 2014|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
VM-1500 + Raltegravir
VM-1500 40 mg in combination with 400 mg Raltegravir
VM-1500 40 mg
400 mg Raltegravir
VM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir
VM-1500 40 mg
Darunavir 600 mg
Ritonavir 100 mg
VM-1500 40 mg alone
VM-1500 40 mg
This drug-drug interaction study will not be done as a cross-over study due to the extreme
long half life of the drug. The 24 healthy subjects participating will be randomized to
VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir in parallel arms.
For the cohort taking VM-1500 40 mg only just 4 subject will be enrolled as 6 subjects have been already on the same regimen in the trial before. Based on the parallel design it seems appropriate not to expose more healthy subjects than necessary. This means the available data of 6 subjects dosed with 40 mg VM-1500 alone will be matched.
Three groups of healthy subjects will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir (4:10:10). The healthy subjects will stay at the unit and receive 40 mg VM-1500 alone or VM1500 in combination with Raltegravir or Darunavir one time and PK blood samples at several time points will be collected. PK (trough level) blood samples will also be collected at visits on Days 2, 4,7, 14, 21, and on Day 36.
|Ages Eligible for Study:||18 Years to 45 Years|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02489487
Locations Show More
|Faculty of Medicine, Siriraj Hospital|
|Bangkok, Wanglang Road, Thailand, 10700|
Sponsors and CollaboratorsViriom
|ClinicalTrials.gov Identifier:||NCT02489487 History of Changes|
|Other Study ID Numbers:||VM-1500-002|
|Study First Received:||June 18, 2015|
|Last Updated:||June 30, 2015|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.