NCT05935917

Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults

A Phase 1, Open-label, Single-dose, Randomized, Two-period, Crossover Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults. Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety. This is an open-label, single-dose, randomized, two-period, crossover study.

Detailed description

Primary Objectives: * To evaluate the bioequivalence (BE) of brincidofovir (BCV) hydrate (Form H) tablet and the Form II tablet when administered under fasting conditions in healthy adult participants. * To characterize plasma BCV pharmacokinetics (PK) following single doses of BCV when administered in healthy adult participants. Safety Objective: \- To evaluate the safety of BCV following administration of single dose of 100 mg BCV Form H and BCV Form II tablet in healthy adult participants.

Conditions

• Smallpox

Interventions

Type	Name	Description
DRUG	Brincidofovir	100 mg tablet of Form H and 100 mg tablet of Form II

Timeline

• Start date: 2023-05-30
• Primary completion: 2023-08-14
• Completion: 2023-09-27
• First posted: 2023-07-07
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study