Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03192111 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function
A Phase 1 study, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03192111: Completed Phase 1 study, sponsored by Syndax Pharmaceuticals.
NCT03192111 is a Phase 1 study that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192111, a Phase 1 study, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment. The primary objective of this study is to evaluate the pharmacokinetics of a single dose of entinostat in adult subjects with mild, moderate and severe renal impairment compared to healthy mean-matched subjects. The secondary objective of this study is to evaluate the safety and tolerability of entinostat in adult subjects with mild, moderate, and severe renal impairment and in healthy mean-matched adult subjects.
Primary Outcome
AUC0-t will be computed for all subjects
Interventions
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-07-27 |
| Est. Completion | 2017-11-23 |
| Phase | Phase 1 |
What the finished NCT03192111 record still lists
NCT03192111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Entinostat is the first listed.
NCT03192111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03192111 about?
NCT03192111 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function". This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment. The primary objective of this study is to evaluate the pharmacokinetics of a single dose of entinostat in adult subjects with mild, moderate and severe renal imp...
What is the current status of trial NCT03192111?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-07-27. Estimated completion is 2017-11-23.
What interventions are being tested in trial NCT03192111?
The interventions under investigation include: Entinostat (DRUG).
Who is sponsoring clinical trial NCT03192111?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03192111's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
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