HIV-1-infectionPhase 1NCT05165550
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
A Phase 1 study testing Elsulfavirine in people with HIV-1-infection, run by Viriom at 1 site in United States.
Trial summary
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Elsulfavirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2022to 13 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18-55 years;
- Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 14 days prior to study drug administration;
- Body weight ≥ 50 kg and a body mass index of 18.5 30 kg/m2, inclusive;
- A negative alcohol and drug screen tests;
- Female subjects must be postmenopausal not less than 2 years, surgically sterile, or if of child-bearing potential, must use two reliable forms of contraception from screening to 3 months after the end of dosing; two reliable forms of contraception include use of condom with spermicide by male partner, or diaphragm with spermicide, or condom use by male partner and diaphragm, or condom use by male partner and non-hormonal intrauterine device.
- Male subjects must use two reliable forms of contraception from screening to 3 months after the end of dosing; two reliable forms of contraception include condom with spermicide, or diaphragm use by female partner with spermicide, or condom and diaphragm use by female partner, or condom and intrauterine device use by female partner.
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- Ability to comprehend the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study;
- Willingness to give written consent to participate after reading the consent form, and after having the opportunity to discuss the study with the investigator or his/her delegate.
- Willingness to comply to all study procedures and assessments as specified by the protocol.
Who cannot join
- Subject participation in more than one treatment group;
- History or presence of any clinically significant organ system disease, such as chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal, gastrointestinal, hepatic, renal, blood or skin disease, that could interfere with the objectives of the study or the safety of the subject;
- Any screening laboratory result outside the normal laboratory reference range and as confirmed upon repeated testing;
- Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug;
- Systolic blood pressure less than 90 mm Hg or higher than 130 mm Hg; diastolic blood pressure less than 60 mm Hg or higher than 85 mm Hg; pulse rate less than 60 beats per minute or more than 90 beats per minute;
- 12-lead ECG with any abnormality or QT/QTc interval of > 450 milliseconds (msec) for men or >470 msec for women;
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- Administration of any prescription drug, over-the-counter drug, or herbal, nutritional, dietary, or vitamin supplement within 14 days of study drug administration, including oral contraceptives; interruption of ongoing oral contraceptive or contraceptive implant birth control is not advised solely for the purpose of this clinical trial participation; Note: Female subjects of child-bearing potential on oral contraceptives or contraceptive implant birth control should discuss this matter with their health care provider.
- Use of the following prescription medications within 5 half-lives of individual agent or within 28 days prior to enrollment, whichever is longer: corticosteroids by any route, other immunosuppressive therapies, drugs that inhibit cytochrome P450 3A4 (CYP3A4; e.g., ritonavir and other drugs of this class for human immunodeficiency virus [HIV] prophylaxis, ketoconazole, itraconazole or similar azole anti-fungal drugs and macrolide antibiotics such as erythromycin) or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine);
- Hepatitis B (HBsAg), HIV or Hepatitis C Virus antibodies, positive syphilis test;
- Positive serum pregnancy test (for women of childbearing potential) at screening or positive urine pregnancy test at Day 1;
- Acute infections within 4 weeks prior to the screening;
- Unstable sleep pattern (for instance, night work shifts, sleep disorders, insomnia, recent return from a different time zone, etc.);
- History of alcohol or drug abuse; alcohol or narcotic consumption within 4 days before the screening and throughout the study, smoking 3 months prior to the screening and throughout the study;
- Positive allergic anamnesis (including drug intolerance and food allergy), including sensitivity to components of the study medication; Specifically, allergies to sulfa drugs and intolerance to lactose will be exclusionary.
- Blood/plasma donations (≥450 mL of blood/plasma) within 2 months prior to the screening;
- Participation in other clinical studies or administration of investigational drugs within 3 months prior to the screening;
- Any other concurrent medical or major psychiatric condition that makes the subject unsuitable for the clinical study;
- Employee of the investigational site or the sponsor, who is directly involved in the study, or a family member of such a person.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc.
Los Angeles, California, 90630
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
Read the detailed description
This study is a double-blind, placebo-controlled, outpatient study of single oral ascending doses of Elsulfavirine to evaluate the safety, tolerability, and pharmacokinetics of Elsulfavirine and its active metabolite VM-1500A in HIV-negative, healthy subjects. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled. Within each of the three cohorts consisting of 8 subjects, 6 subjects each will receive single oral doses of Elsulfavirine at 20 mg, 40 mg, or 80 mg in an escalating manner, and 2 subjects will receive matching placebo.
- Conditions
- HIV-1-infection
- Being tested
- Elsulfavirine
- Keywords
- HIV-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElsulfavirineDrug
Also called VM-1500
Elsulfavirine (Elpida®) 20 mg capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Elsulfavirine 20 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled Receives: Drug: Elsulfavirine |
| Cohort 2 | Experimental | Elsulfavirine 40 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled Receives: Drug: Elsulfavirine |
| Cohort 3 | Experimental | Elsulfavirine 80 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled Receives: Drug: Elsulfavirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of AEs and SAEs.
Measured: 35 days
Secondary outcomes (1)
VM-1500A plasma concentration
Active metabolite plasma concentration
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start12 Apr 2022
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Smith, MD, PhD, Principal investigator, Altasciences Clinical Los Angeles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165550
- Sponsor's protocol ID
- HIV-VM1500-10
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05165550
- Acronym / sponsor ID
- HIV-VM1500-10
- Conditions
- HIV-1-infection
- Keywords
- HIV-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
Detailed description
This study is a double-blind, placebo-controlled, outpatient study of single oral ascending doses of Elsulfavirine to evaluate the safety, tolerability, and pharmacokinetics of Elsulfavirine and its active metabolite VM-1500A in HIV-negative, healthy subjects. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled. Within each of the three cohorts consisting of 8 subjects, 6 subjects each will receive single oral doses of Elsulfavirine at 20 mg, 40 mg, or 80 mg in an escalating manner, and 2 subjects will receive matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ElsulfavirineElsulfavirine 20 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled |
| Cohort 2 | Experimental | Drug: ElsulfavirineElsulfavirine 40 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled |
| Cohort 3 | Experimental | Drug: ElsulfavirineElsulfavirine 80 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women aged 18-55 years;
- Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 14 days prior to study drug administration;
- Body weight ≥ 50 kg and a body mass index of 18.5 30 kg/m2, inclusive;
- A negative alcohol and drug screen tests;
- Female subjects must be postmenopausal not less than 2 years, surgically sterile, or if of child-bearing potential, must use two reliable forms of contraception from screening to 3 months after the end of dosing; two reliable forms of contraception include use of condom with spermicide by male partner, or diaphragm with spermicide, or condom use by male partner and diaphragm, or condom use by male partner and non-hormonal intrauterine device.
Key exclusion criteria (18 listed)
- Subject participation in more than one treatment group;
- History or presence of any clinically significant organ system disease, such as chronic cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal, gastrointestinal, hepatic, renal, blood or skin disease, that could interfere with the objectives of the study or the safety of the subject;
- Any screening laboratory result outside the normal laboratory reference range and as confirmed upon repeated testing;
- Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug;
- Systolic blood pressure less than 90 mm Hg or higher than 130 mm Hg; diastolic blood pressure less than 60 mm Hg or higher than 85 mm Hg; pulse rate less than 60 beats per minute or more than 90 beats per minute;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElsulfavirineAlso: VM-1500Elsulfavirine (Elpida®) 20 mg capsules for oral administration | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
The incidence of AEs and SAEs.
Time frame: 35 days
1 secondary outcome
VM-1500A plasma concentration
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Smith, MD, PhD principal investigator
Altasciences Clinical Los Angeles, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elsulfavirine in people with HIV-1-infection, run by Viriom at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of AEs and SAEs. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.