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

HIV-infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489487
• Other study ID #: VM-1500-002
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2018
• Source: Viriom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection

Intervention

Drug:
• VM-1500
VM-1500 40 mg
• Darunavir
Darunavir 600 mg
• Ritonavir
Ritonavir 100 mg
• Raltegravir
400 mg Raltegravir

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital	Bangkok	Wanglang Road

Sponsors (1)

Lead Sponsor	Collaborator
Viriom

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma concentrations of VM-1500 from Day 1 to Day 36	Plasma concentrations of VM-1500 given alone or in combination with raltegravir or darunavir	36 days
Secondary	Plasma concentrations of VM1500A (active metabolite of VM1500) from Day 1 to Day 36	Plasma concentrations of VM-1500A alone or in combination with raltegravir or darunavir	36 days