Trial · NCT03525886
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
NCT03525886, Phase 2, Completed, Neurocrine Biosciences; results first posted 2022-05-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia. Trials, record NCT03525886. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03525886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
- NCT number
- NCT03525886
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- CAH - Congenital Adrenal Hyperplasia
- Interventions
- NBI-74788
- First posted
- 2018-05-16
- Last updated
- 2022-05-03
- Results first posted
- 2022-05-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Baseline and Day 14 | 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. |
| Secondary | Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Baseline and Day 14 | Percent changes in androstenedione were assessed through the collection of samples from 0600 hours to 1000 hours prior to study drug administration (baseline) and after 14 days of study drug dosing. The 3 samples collected at each visit during this morning window were averaged and used to determine the change and percent change from baseline. |
| Secondary | Percent Change From Baseline to Day 14 in Adrenocorticotropic Hormone (ACTH) Morning Window Averages | Baseline and Day 14 | Percent changes in ACTH were assessed through the collection of samples from 0600 hours to 1000 hours prior to study drug administration (baseline) and after 14 days of study drug dosing. The 3 samples collected at each visit during this morning window were averaged and used to determine the change and percent change from baseline. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Baseline and Day 14 | Pharmacodynamic (PD) analysis set, which includes all enrolled participants who received at least one dose of study drug and have at least one PD parameter measurement at baseline and at least one PD parameter measurement at the Day 14 visit. | Percent (%) | MEDIAN |
| SECONDARY | Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Baseline and Day 14 | Pharmacodynamic (PD) analysis set, which includes all enrolled participants who received at least one dose of study drug and have at least one PD parameter measurement at baseline and at least one PD parameter measurement at the Day 14 visit. | Percent (%) | MEDIAN |
| SECONDARY | Percent Change From Baseline to Day 14 in Adrenocorticotropic Hormone (ACTH) Morning Window Averages | Baseline and Day 14 | Pharmacodynamic analysis set, which includes all enrolled participants who received at least one dose of study drug and have at least one PD parameter measurement at baseline and at least one PD parameter measurement at the Day 14 visit. | Percent (%) | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Cohort 1 (50 mg QHS) | -60 | Inter-Quartile Range -85 to -32 | Percent (%) | |
| Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Cohort 2 (100 mg QHS) | -58 | Inter-Quartile Range -93 to 8 | Percent (%) | |
| Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Cohort 3 (100 mg QPM) | -53 | Inter-Quartile Range -86 to -43 | Percent (%) | |
| Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages | Cohort 4 (100 mg BID) | -64 | Inter-Quartile Range -86 to -51 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Cohort 1 (50 mg QHS) | -21 | Inter-Quartile Range -55 to -7 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Cohort 2 (100 mg QHS) | -42 | Inter-Quartile Range -70 to -23 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Cohort 3 (100 mg QPM) | -51 | Inter-Quartile Range -70 to 50 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages | Cohort 4 (100 mg BID) | -64 | Inter-Quartile Range -68 to -52 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Adrenocorticotropic Hormone (ACTH) Morning Window Averages | Cohort 1 (50 mg QHS) | -54 | Inter-Quartile Range -75 to -32 | Percent (%) | |
| Percent Change From Baseline to Day 14 in Adrenocorticotropic Hormone (ACTH) Morning Window Averages | Cohort 2 (100 mg QHS) | -63 | Inter-Quartile Range -80 to -39 | Percent (%) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 (50 mg QHS) | STARTED | Cohort 1 (50 mg QHS) | 8 | |
| Cohort 1 (50 mg QHS) | STARTED | Cohort 2 (100 mg QHS) | 0 | |
| Cohort 1 (50 mg QHS) | STARTED | Cohort 3 (100 mg QPM) | 0 | |
| Cohort 1 (50 mg QHS) | STARTED | Cohort 4 (100 mg BID) | 0 | |
| Cohort 1 (50 mg QHS) | COMPLETED | Cohort 1 (50 mg QHS) | 8 | |
| Cohort 1 (50 mg QHS) | COMPLETED | Cohort 2 (100 mg QHS) | 0 | |
| Cohort 1 (50 mg QHS) | COMPLETED | Cohort 3 (100 mg QPM) | 0 | |
| Cohort 1 (50 mg QHS) | COMPLETED | Cohort 4 (100 mg BID) | 0 | |
| Cohort 1 (50 mg QHS) | NOT COMPLETED | Cohort 1 (50 mg QHS) | 0 | |
| Cohort 1 (50 mg QHS) | NOT COMPLETED | Cohort 2 (100 mg QHS) | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Cohort 1 (50 mg QHS) | 0 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Cohort 2 (100 mg QHS) | 1 | 7 | |
| other | Dyspepsia | Gastrointestinal disorders | Cohort 3 (100 mg QPM) | 0 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Cohort 4 (100 mg BID) | 0 | 8 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Cohort 1 (50 mg QHS) | 0 | 8 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Cohort 2 (100 mg QHS) | 1 | 7 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Cohort 3 (100 mg QPM) | 0 | 8 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Cohort 4 (100 mg BID) | 0 | 8 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1 (50 mg QHS) | 1 | 8 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2 (100 mg QHS) | 1 | 7 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (50 mg QHS) | 0 | 8 |
| Total, all-cause mortality | Cohort 2 (100 mg QHS) | 0 | 7 |
| Total, all-cause mortality | Cohort 3 (100 mg QPM) | 0 | 8 |
| Total, all-cause mortality | Cohort 4 (100 mg BID) | 0 | 8 |
| Total, other adverse events | Cohort 1 (50 mg QHS) | 7 | 8 |
| Total, other adverse events | Cohort 2 (100 mg QHS) | 5 | 7 |
| Total, other adverse events | Cohort 3 (100 mg QPM) | 5 | 8 |
| Total, other adverse events | Cohort 4 (100 mg BID) | 5 | 8 |
| Total, serious adverse events | Cohort 1 (50 mg QHS) | 0 | 8 |
| Total, serious adverse events | Cohort 2 (100 mg QHS) | 1 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34653252 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03525886
GET https://conductscience.org/api/trials/v1/NCT03525886/flow?page=2