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Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730311
Recruitment Status : Unknown
Verified May 2019 by Viriom.
Recruitment status was:  Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Viriom

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Elpida Drug: placebo Phase 1

Detailed Description:
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind study
Primary Purpose: Treatment
Official Title: Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: Elpida 120 mg once weekly
elsulfavirine 120mg or placebo orally once weekly for 4 weeks
 Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM-1500
  • VM1500

Drug: placebo
placebo
Experimental: Elpida 200 mg once weekly
elsulfavirine 200mg or placebo orally once weekly for 4 weeks
 Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM-1500
  • VM1500

Drug: placebo
placebo
Experimental: Elpida 280 mg once weekly
elsulfavirine 280mg or placebo orally once weekly for 4 weeks
 Drug: Elpida
elsulfavirine, capsules
Other Names:
  • elsulfavirine
  • VM-1500
  • VM1500

Drug: placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of AEs and SAEs [ Time Frame: 36 days ]
    Incidence of AEs and SAEs


Secondary Outcome Measures :
  1. elsulfavirine plasma concentration [ Time Frame: 36 days ]
    elsulfavirine plasma concentration

  2. VM1500A plasma concentration [ Time Frame: 36 days ]
    active metabolite plasma concentration


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males or females aged between 18-40 years.
  2. Willing and able to complete all study procedures, visits and restrictions.
  3. Capable of giving written informed consent.
  4. Has been determined healthy by medical history, physical and vital signs examinations.
  5. 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.
  6. 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.

  7. 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:

    • Condoms (male or female) with or without a spermicidal agent;
    • Diaphragm or cervical cap with spermicide;
    • Intrauterine device (IUD);
    • Hormonal-based contraception. Participants who are not of reproductive potential (women who have been postmenopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation or men who have documented azoospermia) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization, menopause or male partner's azoospermia must be provided; serum follicle stimulating hormone (FSH) measurement can be used to document menopausal range.

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. Clinically significant ECG abnormality according to ECG exam at Screening, subject's medical history or family history judged by the Investigator that the presence of, or an increased risk of cardiac abnormality.
  3. Positive result for HIV, HCV or HBV at Screening.
  4. Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or cocaine) or alcohol screen at Screening.
  5. Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  6. Received the excluded medications (as shown in Appendix 3) within 14 days or 28 days prior to the first dose of study drug, or within the 5 half-lives of individual medication, whichever is longer.
  7. Participated in a clinical study and received any investigational drug or vaccine or medical device within 90 days prior to the first dose of study drug.
  8. Pregnancy or breast feeding, male partners of pregnant females. Inability to understand the Protocol or follow its instructions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730311


Contacts
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Contact: Tapanee Mahasanprasert +66(0) 2 412-1315 tapanee.mahasanprasert@aclires.com

Locations
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Thailand
Siriraj Hospital
Bangkok, Thailand
Contact: Somruedee Chatsiricharoenkul, Assoc. Prof., MD    +66 (0)2 412 1315      
Sponsors and Collaborators
Viriom
Investigators
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Principal Investigator: Somruedee Chatsiricharoenkul, Assoc. Prof., MD Siriraj Hospital Bangkok, Thailand
More Information
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Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT03730311    
Other Study ID Numbers: HIV-VM1500-11
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Elsulfavirine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents