At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
NBI-74788drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects With Congenital Adrenal Hyperplasia
In Brief
A Phase 2 clinical trial evaluating NBI-74788 for CAH - Congenital Adrenal Hyperplasia. Completed, enrolled 18 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCAH - Congenital Adrenal Hyperplasia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
First PostedMay 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedMay 16, 2018
Enrollment StartApr 10, 2018
Primary CompletionApr 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.1 years ago
Interventions
NBI-74788drug
Capsule, administered daily.