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Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD

NCT05962645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-07-30

No results posted yet for this study

Summary

Vapendavir (VPV) is potent virostatic antiviral agent active against all known enterovirus species. VPV binds to the viral capsid, thereby inhibiting viral attachment to the target cell and, independently, preventing release of viral RNA (ribonucleic acid) into the cell. Alt VPV-101 is meant to investigate vapendavir in patients with chronic obstructive pulmonary disease (COPD) who develop a rhinoviral infection. This is a Phase 1, open-label, unblinded study. The primary objective of this study is to characterize single and multiple dose (plus a loading dose) plasma PK profiles of VPV in healthy participants (Group A) and participants with COPD (Group B). Group A is an open-label, 2-sequence, and up to a 3-period, cross-over study to assess the single-dose PK parameters and safety of VPV. Healthy participants may opt to participate in only the first 2 periods, all 3 periods or BID dosing, but it is preferred that participants complete all 3 periods. Group B is an open-label, multi-dose investigation of VPV PK parameters and safety in participants with COPD. Post-dose, follow up will continue for a minimum of 14 days and a maximum of 30 days, depending on which Group the participant is in and which periods said participant completes. There is a target for up to 24 adult participants comprised of healthy participants and participants with COPD.

Conditions

  • COPD
  • Respiratory Disease
  • Lower Respiratory Disease
  • Pulmonary Disease
  • Healthy

Interventions

DRUG

Vapendavir

This study will measure and compare how VPV is absorbed in the blood, broken down in the body and eliminated when two 250 mg VPV tablets (500mg) are given in three different ways: A single dose, once a day, under fasted conditions (without any food); twice a day, for 7 days; and a single dose, once a day under fed conditions, after consuming a high-fat meal.

Sponsors & Collaborators

  • Altesa Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wyatt, MD · VP Medical Affairs

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2023-12-12
Completion
2024-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05962645 on ClinicalTrials.gov