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

• ClinicalTrials.gov Identifier: NCT03730311
• Recruitment Status: Unknown
• First Posted: November 5, 2018
• Last Update Posted: May 20, 2019
• Sponsor: Viriom
• Information provided by (Responsible Party): Viriom

Tracking Information

• First Submitted Date: November 1, 2018
• First Posted Date: November 5, 2018
• Last Update Posted Date: May 20, 2019
• Estimated Study Start Date: May 2019
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 1, 2018)

Incidence of AEs and SAEs [ Time Frame: 36 days ]

Incidence of AEs and SAEs

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 1, 2018)

• elsulfavirine plasma concentration [ Time Frame: 36 days ]
  elsulfavirine plasma concentration
• VM1500A plasma concentration [ Time Frame: 36 days ]
  active metabolite plasma concentration

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
• Official Title: Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
• 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.
• Detailed Description: The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Double-blind study

Primary Purpose: Treatment

• Condition: HIV Infections

Intervention

• Drug: Elpida
  elsulfavirine, capsules
  Other Names:

  • elsulfavirine
  • VM-1500
  • VM1500
• Drug: placebo
  placebo

Study Arms

• Experimental: Elpida 120 mg once weekly
  elsulfavirine 120mg or placebo orally once weekly for 4 weeks
  Interventions:

  • Drug: Elpida
  • Drug: placebo
• Experimental: Elpida 200 mg once weekly
  elsulfavirine 200mg or placebo orally once weekly for 4 weeks
  Interventions:

  • Drug: Elpida
  • Drug: placebo
• Experimental: Elpida 280 mg once weekly
  elsulfavirine 280mg or placebo orally once weekly for 4 weeks
  Interventions:

  • Drug: Elpida
  • Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 1, 2018): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT03730311
• Other Study ID Numbers: HIV-VM1500-11
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Viriom
• Original Responsible Party: Same as current
• Current Study Sponsor: Viriom
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Somruedee Chatsiricharoenkul, Assoc. Prof., MD; Siriraj Hospital Bangkok, Thailand

• PRS Account: Viriom
• Verification Date: May 2019