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
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ClinicalTrials.gov Identifier: NCT05165550 |
Recruitment Status :
Completed
First Posted : December 21, 2021
Last Update Posted : February 21, 2023
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Sponsor:
Viriom
Information provided by (Responsible Party):
Viriom
Tracking Information | |||||
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First Submitted Date ICMJE | December 7, 2021 | ||||
First Posted Date ICMJE | December 21, 2021 | ||||
Last Update Posted Date | February 21, 2023 | ||||
Actual Study Start Date ICMJE | April 12, 2022 | ||||
Actual Primary Completion Date | July 13, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The incidence of AEs and SAEs. [ Time Frame: 35 days ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
VM-1500A plasma concentration [ Time Frame: 35 days ] Active metabolite plasma concentration
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | HIV-1-infection | ||||
Intervention ICMJE | Drug: Elsulfavirine
Elsulfavirine (Elpida®) 20 mg capsules for oral administration
Other Name: VM-1500
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 13, 2022 | ||||
Actual Primary Completion Date | July 13, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05165550 | ||||
Other Study ID Numbers ICMJE | HIV-VM1500-10 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Viriom | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Viriom | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Viriom | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |