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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VM-1500 + Raltegravir | Experimental | VM-1500 40 mg in combination with 400 mg Raltegravir |
|
| VM-1500 +Darunavir | Experimental | VM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir |
|
| VM-1500 | Experimental | VM-1500 40 mg alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VM-1500 | Drug | VM-1500 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma concentrations of VM1500A (active metabolite of VM1500) from Day 1 to Day 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Somruedee Chatsiricharoenkul, MD | Acriles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Siriraj Hospital | Bangkok | Wanglang Road | 10700 | Thailand |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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| Darunavir | Drug | Darunavir 600 mg |
|
| Ritonavir | Drug | Ritonavir 100 mg |
|
| Raltegravir | Drug | 400 mg Raltegravir |
|
Plasma concentrations of VM-1500A alone or in combination with raltegravir or darunavir
| 36 days |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |