Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT05935917 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess maximum observed plasma concentration of Brincidofovir
Interventions
- DRUG Brincidofovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-05-30 |
| Est. Completion | 2023-09-27 |
| Phase | Phase 1 |
What the finished NCT05935917 record still lists
NCT05935917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which Brincidofovir is the first listed.
NCT05935917 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05935917's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI