Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04413552 · ClinicalTrials.gov registry record · Phase 1
INDV-2000 First in Human
A Phase 1 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT04413552: Completed Phase 1 study, sponsored by Indivior.
NCT04413552 is a Phase 1 study that has completed, run by Indivior. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413552, a Phase 1 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will be conducted.
Primary Outcome
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome.
Interventions
- DRUG Placebo
- DRUG INDV-2000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2021-04-13 |
| Phase | Phase 1 |
What the finished NCT04413552 record still lists
NCT04413552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04413552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04413552 about?
NCT04413552 is a clinical study titled "INDV-2000 First in Human". This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will be conducted.
What is the current status of trial NCT04413552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2020-07-06. Estimated completion is 2021-04-13.
What interventions are being tested in trial NCT04413552?
The interventions under investigation include: Placebo (DRUG), INDV-2000 (DRUG).
Who is sponsoring clinical trial NCT04413552?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04413552's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 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
- NCT03661307 · 73 participants · Phase 1
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
- NCT05386108 · 73 participants · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- NCT05961592 · 73 participants · Phase 1
R-2487 in Patients With Rheumatoid Arthritis
- NCT06150664 · 73 participants · Phase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
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