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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05935917
Study type Interventional
Source Emergent BioSolutions
Contact
Status Completed
Phase Phase 1
Start date May 30, 2023
Completion date September 27, 2023

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