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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 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525886
The ClinicalTrials.gov registry entry for NCT03525886 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NBI-74788 is the first listed.
NCT03525886 reports 0 study locations.
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.
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