CompletedPhase 1

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

United States44 participantsStarted 2023-05-30

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Alanine transaminase (ALT), aspartate aminotransferase (AST) and gammaglutamyl transferase (GGT) x ≤1.5 upper limit of normal reference range (ULN)
. Total Bilirubin x ≤1.5 ULN
. Hemoglobin (Hb) ≥10.5 g/dL for females or ≥12 g/dL for males

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK endpoint - Peak Plasma Concentration (Cmax)

Timeframe: Through 96 hours post-dose

PK endpoint - AUClast

Timeframe: Through 96 hours post-dose

PK endpoint - AUCinf

Timeframe: Through 96 hours post-dose

Incidence of treatment adverse events (AEs)

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Heart Rate

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Respiratory Rate

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Trial details

NCT IDNCT05935917

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-14

View on ClinicalTrials.gov More Smallpox trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Alanine transaminase (ALT), aspartate aminotransferase (AST) and gammaglutamyl transferase (GGT) x ≤1.5 upper limit of normal reference range (ULN)
. Total Bilirubin x ≤1.5 ULN
. Hemoglobin (Hb) ≥10.5 g/dL for females or ≥12 g/dL for males

What they're measuring

PK endpoint - Peak Plasma Concentration (Cmax)

Timeframe: Through 96 hours post-dose

PK endpoint - AUClast

Timeframe: Through 96 hours post-dose

PK endpoint - AUCinf

Timeframe: Through 96 hours post-dose

Incidence of treatment adverse events (AEs)

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Heart Rate

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Respiratory Rate

Timeframe: Through end of study visit (within 14 days after 2nd dose)

Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)

Timeframe: Through end of study visit (within 14 days after 2nd dose)