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

Sponsor

Viriom (Industry)

Overall Status

Completed

CT.gov ID

NCT02489487

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

24.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-infection	Drug: VM-1500 Drug: Darunavir Drug: Ritonavir Drug: Raltegravir	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VM-1500 + Raltegravir VM-1500 40 mg in combination with 400 mg Raltegravir	Drug: VM-1500 VM-1500 40 mg Drug: Raltegravir 400 mg Raltegravir
Experimental: VM-1500 +Darunavir VM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir	Drug: VM-1500 VM-1500 40 mg Drug: Darunavir Darunavir 600 mg Drug: Ritonavir Ritonavir 100 mg
Experimental: VM-1500 VM-1500 40 mg alone	Drug: VM-1500 VM-1500 40 mg

Arm

Intervention/Treatment

Experimental: VM-1500 + Raltegravir

VM-1500 40 mg in combination with 400 mg Raltegravir

Drug: VM-1500

VM-1500 40 mg

Drug: Raltegravir

400 mg Raltegravir

Experimental: VM-1500 +Darunavir

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

Drug: VM-1500

VM-1500 40 mg

Drug: Darunavir

Darunavir 600 mg

Drug: Ritonavir

Ritonavir 100 mg

Experimental: VM-1500

VM-1500 40 mg alone

Drug: VM-1500

VM-1500 40 mg

Outcome Measures

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 [36 days]
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 [36 days]
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 [36 days]
Plasma concentrations of VM-1500A alone or in combination with raltegravir or darunavir

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Siriraj Hospital	Bangkok	Wanglang Road	Thailand	10700

Sponsors and Collaborators

Viriom

Investigators

Principal Investigator: Somruedee Chatsiricharoenkul, MD, Acriles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Viriom

ClinicalTrials.gov Identifier:

NCT02489487

Other Study ID Numbers:

VM-1500-002

First Posted:

Jul 3, 2015

Last Update Posted:

Oct 4, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

HIV Infections

Ritonavir

Darunavir

Raltegravir Potassium

Study Results

No Results Posted as of Oct 4, 2018