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

NCT05935917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-01-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

Brincidofovir

100 mg tablet of Form H and 100 mg tablet of Form II

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Dave Cassie, MSc · Director, Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2023-08-14
Completion
2023-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05935917 on ClinicalTrials.gov