Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia (NCT NCT03525886)
NCT ID: NCT03525886
Last Updated: 2022-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline and Day 14
Results posted on
2022-05-03
Participant Flow
The study followed a sequential cohort design with four NBI-74788 dosing regimens, each administered for 14 consecutive days. There was \~2-week period to evaluate safety and tolerability data before proceeding from Cohort 1 to Cohort 2. Subjects who previously completed the study in Cohort 1 or 2 (and had no safety concerns) could reenroll into Cohorts 3 and/or 4 (in addition to new subjects); 18 unique subjects participated. First subject enrolled: 4/10/2018; Last subject completed: 4/7/2020
Participant milestones
| Measure |
Cohort 1 (50 mg QHS)
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Cohort 1 (50 mg QHS)
STARTED
|
8
|
0
|
0
|
0
|
|
Cohort 1 (50 mg QHS)
COMPLETED
|
8
|
0
|
0
|
0
|
|
Cohort 1 (50 mg QHS)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2 (100 mg QHS)
STARTED
|
0
|
7
|
0
|
0
|
|
Cohort 2 (100 mg QHS)
COMPLETED
|
0
|
7
|
0
|
0
|
|
Cohort 2 (100 mg QHS)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 3 (100 mg QPM)
STARTED
|
0
|
0
|
8
|
0
|
|
Cohort 3 (100 mg QPM)
COMPLETED
|
0
|
0
|
8
|
0
|
|
Cohort 3 (100 mg QPM)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 4 (100 mg BID)
STARTED
|
0
|
0
|
0
|
8
|
|
Cohort 4 (100 mg BID)
COMPLETED
|
0
|
0
|
0
|
8
|
|
Cohort 4 (100 mg BID)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
Baseline characteristics by cohort
| Measure |
Cohort 1 (50 mg QHS)
n=8 Participants
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 Participants
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 Participants
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 Participants
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · Asian
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · Black or African American
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · White
|
—
|
—
|
—
|
8 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
8 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · More than one race
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 4 (100 mg BID) · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Age, Continuous
Cohort 1 (50 mg QHS)
|
31.1 years
STANDARD_DEVIATION 9.4 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
31.1 years
STANDARD_DEVIATION 9.4 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Age, Continuous
Cohort 2 (100 mg QHS)
|
—
|
32.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
32.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Age, Continuous
Cohort 3 (100 mg QPM)
|
—
|
—
|
30.9 years
STANDARD_DEVIATION 10.5 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
30.9 years
STANDARD_DEVIATION 10.5 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Age, Continuous
Cohort 4 (100 mg BID)
|
—
|
—
|
—
|
28.8 years
STANDARD_DEVIATION 8.2 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
28.8 years
STANDARD_DEVIATION 8.2 • n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 1 (50 mg QHS) · Female
|
4 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
4 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 1 (50 mg QHS) · Male
|
4 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
4 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 2 (100 mg QHS) · Female
|
—
|
5 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
5 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 2 (100 mg QHS) · Male
|
—
|
2 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
2 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 3 (100 mg QPM) · Female
|
—
|
—
|
3 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
3 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 3 (100 mg QPM) · Male
|
—
|
—
|
5 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
5 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 4 (100 mg BID) · Female
|
—
|
—
|
—
|
5 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
5 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Sex: Female, Male
Cohort 4 (100 mg BID) · Male
|
—
|
—
|
—
|
3 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
3 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (50 mg QHS) · Hispanic or Latino
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (50 mg QHS) · Not Hispanic or Latino
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (50 mg QHS) · Unknown or Not Reported
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (100 mg QHS) · Hispanic or Latino
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (100 mg QHS) · Not Hispanic or Latino
|
—
|
7 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
7 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (100 mg QHS) · Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (100 mg QPM) · Hispanic or Latino
|
—
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (100 mg QPM) · Not Hispanic or Latino
|
—
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (100 mg QPM) · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (100 mg BID) · Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (100 mg BID) · Not Hispanic or Latino
|
—
|
—
|
—
|
8 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
8 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (100 mg BID) · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · American Indian or Alaska Native
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · Asian
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · Black or African American
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · White
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · More than one race
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
0 Participants
A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 1 (50 mg QHS) · Unknown or Not Reported
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · Asian
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · Black or African American
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · White
|
—
|
7 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
7 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · More than one race
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 2 (100 mg QHS) · Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
—
|
0 Participants
n=7 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · Asian
|
—
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
1 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · Black or African American
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · White
|
—
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
7 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · More than one race
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
|
Race (NIH/OMB)
Cohort 3 (100 mg QPM) · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
—
|
0 Participants
n=8 Participants • A total of 18 unique subjects participated in the study. Subjects could participate in more than one cohort; Cohort 3 included 8 subjects and Cohort 4 included 5 subjects who had participated in other cohorts.
|
PRIMARY outcome
Timeframe: Baseline and Day 14Population: 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 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.
Outcome measures
| Measure |
Cohort 1 (50 mg QHS)
n=8 Participants
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 Participants
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 Participants
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 Participants
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Day 14 in 17-hydroxyprogesterone (17-OHP) Morning Window Averages
|
-60 Percent (%)
Interval -85.0 to -32.0
|
-58 Percent (%)
Interval -93.0 to 8.0
|
-53 Percent (%)
Interval -86.0 to -43.0
|
-64 Percent (%)
Interval -86.0 to -51.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: 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 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.
Outcome measures
| Measure |
Cohort 1 (50 mg QHS)
n=8 Participants
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 Participants
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 Participants
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 Participants
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Day 14 in Androstenedione Morning Window Averages
|
-21 Percent (%)
Interval -55.0 to -7.0
|
-42 Percent (%)
Interval -70.0 to -23.0
|
-51 Percent (%)
Interval -70.0 to 50.0
|
-64 Percent (%)
Interval -68.0 to -52.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: 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 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.
Outcome measures
| Measure |
Cohort 1 (50 mg QHS)
n=8 Participants
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 Participants
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 Participants
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 Participants
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Percent Change From Baseline to Day 14 in Adrenocorticotropic Hormone (ACTH) Morning Window Averages
|
-54 Percent (%)
Interval -75.0 to -32.0
|
-63 Percent (%)
Interval -80.0 to -39.0
|
-64 Percent (%)
Interval -87.0 to -3.0
|
-66 Percent (%)
Interval -78.0 to -47.0
|
Adverse Events
Cohort 1 (50 mg QHS)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2 (100 mg QHS)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 (100 mg QPM)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4 (100 mg BID)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (50 mg QHS)
n=8 participants at risk
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 participants at risk
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 participants at risk
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 participants at risk
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
Other adverse events
| Measure |
Cohort 1 (50 mg QHS)
n=8 participants at risk
NBI-74788 50 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 2 (100 mg QHS)
n=7 participants at risk
NBI-74788 100 mg once daily at bedtime (QHS) administered orally for 14 consecutive days.
|
Cohort 3 (100 mg QPM)
n=8 participants at risk
NBI-74788 100 mg once daily in the evening (QPM) administered orally for 14 consecutive days.
|
Cohort 4 (100 mg BID)
n=8 participants at risk
NBI-74788 100 mg twice daily (BID) administered orally for 14 consecutive days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
General disorders
Fatigue
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
General disorders
Feeling abnormal
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
General disorders
Malaise
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Infections and infestations
Localised infection
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
25.0%
2/8 • Up to 7 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
37.5%
3/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
2/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Reproductive system and breast disorders
Ovulation pain
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • Up to 7 weeks
|
14.3%
1/7 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Up to 7 weeks
|
0.00%
0/7 • Up to 7 weeks
|
12.5%
1/8 • Up to 7 weeks
|
0.00%
0/8 • Up to 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the PI has the right to publish results provided such publication does not violate confidentiality or IP provisions within the contract with the Sponsor. Prior to submission for publication or presentation of results, the PI must provide the Sponsor time for review. The Sponsor can request the PI to withhold or remove information from all publications. For a multi-center study, any publication of results by the PI shall not be made before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER