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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

NCT05165550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-02-21

No results posted yet for this study

Summary

To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.

Conditions

Interventions

DRUG

Elsulfavirine

Elsulfavirine (Elpida®) 20 mg capsules for oral administration

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Brett Smith, MD, PhD · Altasciences Clinical Los Angeles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2022-07-13
Completion
2022-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165550 on ClinicalTrials.gov