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A randomized, placebo-controlled, once weekly dose for four weeks, double blind study in Healthy HIV-Uninfected Volunteers. Each of 3 consequent groups (120 mg, 200 mg and 280mg) enrolls 6 active and 2 placebo subjects.
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elpida 120 mg once weekly | Experimental | elsulfavirine 120mg or placebo orally once weekly for 4 weeks |
|
| Elpida 200 mg once weekly | Experimental | elsulfavirine 200mg or placebo orally once weekly for 4 weeks |
|
| Elpida 280 mg once weekly | Experimental | elsulfavirine 280mg or placebo orally once weekly for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpida | Drug | elsulfavirine, capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs and SAEs | Incidence of AEs and SAEs | 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| elsulfavirine plasma concentration | elsulfavirine plasma concentration | 36 days |
| VM1500A plasma concentration | active metabolite plasma concentration |
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Inclusion Criteria:
Healthy males or females aged between 18-40 years.
Willing and able to complete all study procedures, visits and restrictions.
Capable of giving written informed consent.
Has been determined healthy by medical history, physical and vital signs examinations.
Has normal results for the following screening tests: complete blood count (CBC), sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar (FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and urinalysis.
Females of reproductive potential (defined as women who have not been postmenopausal for at least 24 consecutive months [i.e., who have had menses within the preceding 24 months], or women who have not undergone surgical sterilization; specifically hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation), must have a negative serum or urine pregnancy test with a sensitivity of at least 40 mIU/mL at Screening and prior to drug dosing on Day 1.
All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the participant must agree to use two reliable methods of contraception simultaneously while receiving study treatment and for 6 months after stopping study drug. Subjects must either be abstinent or a combination of TWO of the following methods MUST be used appropriately:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tapanee Mahasanprasert | Contact | +66(0) 2 412-1315 | tapanee.mahasanprasert@aclires.com |
| Name | Affiliation | Role |
|---|---|---|
| Somruedee Chatsiricharoenkul, Assoc. Prof., MD | Siriraj Hospital Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok | Thailand |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000718630 | elsulfavirine |
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Double-blind study
| placebo | Drug | placebo |
|
| 36 days |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |