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

Primary Purpose

HIV-infection

Status

Completed

Phase

Phase 1

Locations

Thailand

Study Type

Interventional

Intervention

VM-1500

Darunavir

Ritonavir

Raltegravir

About this trial

This is an interventional treatment trial for HIV-infection

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Faculty of Medicine, Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

VM-1500 + Raltegravir

VM-1500 +Darunavir

VM-1500

Arm Description

VM-1500 40 mg in combination with 400 mg Raltegravir

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

VM-1500 40 mg alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02489487

First Posted

June 18, 2015

Last Updated

October 2, 2018

Sponsor

Viriom

1. Study Identification

Unique Protocol Identification Number

NCT02489487

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viriom

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VM-1500 + Raltegravir

Arm Type

Experimental

Arm Description

VM-1500 40 mg in combination with 400 mg Raltegravir

Arm Title

VM-1500 +Darunavir

Arm Type

Experimental

Arm Description

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

Arm Title

VM-1500

Arm Type

Experimental

Arm Description

VM-1500 40 mg alone

Intervention Type

Drug

Intervention Name(s)

VM-1500

Intervention Description

VM-1500 40 mg

Intervention Type

Drug

Intervention Name(s)

Darunavir

Intervention Description

Darunavir 600 mg

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Intervention Description

Ritonavir 100 mg

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Intervention Description

400 mg Raltegravir

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

36 days

Secondary Outcome Measure Information:

Title

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

Description

Plasma concentrations of VM-1500 given alone or in combination with raltegravir or darunavir

Time Frame

36 days

Title

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

Description

Plasma concentrations of VM-1500A alone or in combination with raltegravir or darunavir

Time Frame

36 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Somruedee Chatsiricharoenkul, MD

Organizational Affiliation

Acriles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Siriraj Hospital

City

Bangkok

State/Province

Wanglang Road

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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