NCT05962645

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

A Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Altesa Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Vapendavir (VPV) has been in development for the treatment of infections with human rhinovirus (RV) and other respiratory enteroviruses for over a decade, with over 640 healthy adults and participants with Asthma receiving treatment across 7 clinical studies. Vapendavir is a potent and broad spectrum virostatic agent active against \> 97% of RV A and B serotypes (no available assay for RV C, but clinical data indicate sensitivity similar to A and B), and 89% of other enteroviruses evaluated. Vapendavir has exhibited an acceptable safety and tolerability profile, to date, with no appreciable safety concerns with single doses up to 1056 milligram (mg) and daily doses up to 528 mg (264 mg twice daily), for up to 6 or 10 days.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-19
• Primary completion: 2023-12-12
• Completion: 2024-05-02
• First posted: 2023-07-27
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study