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NCT03525886 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03525886: Completed Phase 2 study, sponsored by Neurocrine Biosciences.
NCT03525886 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525886, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult female and male subjects (18 to 50 years of age) with a documented medical diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The study will include a sequential-cohort design with four NBI-74788 dosing regimens, with each regimen administered for 14 days.
Primary Outcome
Percent changes in 17-OHP were assessed through the collection of samples from 0600 hours to 1000 hours both prior to study drug administration (i.e., at baseline) and after 14 days of study drug dosing. The 3 samples collected during this morning window at each visit were averaged and used to determine the percent change from baseline.
Interventions
- DRUG NBI-74788
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2020-04-07 |
| Phase | Phase 2 |
What the finished NCT03525886 record still lists
NCT03525886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which NBI-74788 is the first listed.
NCT03525886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03525886 about?
NCT03525886 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia". This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult female and male subjects (18 to 50 years of age) with a documented medical diagnosis of classic 21-hydroxylase defic...
What is the current status of trial NCT03525886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2018-04-10. Estimated completion is 2020-04-07.
What interventions are being tested in trial NCT03525886?
The interventions under investigation include: NBI-74788 (DRUG).
Who is sponsoring clinical trial NCT03525886?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03525886's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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