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

Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Drug: placebo; Drug: Elpida

Detailed Description

The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elpida 120 mg once weekly; elsulfavirine 120mg or placebo orally once weekly for 4 weeks	Drug: placebo; placebo; Drug: Elpida; elsulfavirine, capsules; Other Names: elsulfavirine; VM1500; VM-1500
Experimental: Elpida 200 mg once weekly; elsulfavirine 200mg or placebo orally once weekly for 4 weeks	Drug: placebo; placebo; Drug: Elpida; elsulfavirine, capsules; Other Names: elsulfavirine; VM1500; VM-1500
Experimental: Elpida 280 mg once weekly; elsulfavirine 280mg or placebo orally once weekly for 4 weeks	Drug: placebo; placebo; Drug: Elpida; elsulfavirine, capsules; Other Names: elsulfavirine; VM1500; VM-1500

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs and SAEs	Incidence of AEs and SAEs	36 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
elsulfavirine plasma concentration	elsulfavirine plasma concentration	36 days
VM1500A plasma concentration	active metabolite plasma concentration	36 days

Collaborators and Investigators

• Sponsor: Viriom
• Investigators: Principal Investigator: Somruedee Chatsiricharoenkul, Assoc. Prof., MD, Siriraj Hospital Bangkok, Thailand

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elsulfavirine
• Other Study ID Numbers: HIV-VM1500-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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