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NCT05935917 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Emergent BioSolutions.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT05935917 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 44 participants.

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The verdict

NCT05935917, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study 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.

Interventions

  • DRUG Brincidofovir

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2023-05-30
Est. Completion 2023-09-27
Phase Phase 1

Sponsor

Emergent BioSolutions

34 total trials

What the Registry Record Tells You About NCT05935917

The ClinicalTrials.gov registry entry for NCT05935917 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Brincidofovir is the first listed.

NCT05935917 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05935917 about?

NCT05935917 is a clinical study titled "Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults". 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 unde...

What is the current status of trial NCT05935917?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2023-05-30. Estimated completion is 2023-09-27.

What interventions are being tested in trial NCT05935917?

The interventions under investigation include: Brincidofovir (DRUG).

Who is sponsoring clinical trial NCT05935917?

This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.