Trial Outcomes & Findings for Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia (NCT NCT03257462)
NCT ID: NCT03257462
Last Updated: 2025-10-22
Results Overview
Incidence of treatment-emergent adverse events, changes from Baseline to End-of-study in clinical laboratory parameters, physical examination findings, vital signs, ECG parameters
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-10-22
Participant Flow
No participants enrolled in Period 4: Cohort D
A total of 24 subjects were enrolled into the study and 24 ICFs were signed. Two subjects were enrolled in more than one cohort: one subject was enrolled in both Cohorts A and C and one subject was enrolled in both in Cohorts A and B. Therefore, the total when adding Cohorts A+B+C = 26; however, 2 subject were the same, thus a total of 24 unique subjects participated and signed the ICFs.
Participant milestones
| Measure |
Period 1: Cohort A
The first cohort of 9 patients underwent dose escalation through 3 dose levels of tildacerfont capsules, beginning with 200 mg QD for 2 weeks, then escalating to 600 mg QD/day for 2 weeks, then escalating to 1000 mg QD for 2 weeks with no washout between dose levels.
|
Period 2: Cohort B
Cohort B will begin enrollment after Cohort A has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort B was administered tildacerfont 200 mg BID during the treatment period.
|
Period 3: Cohort C
Cohort C will begin enrollment after Cohort B has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort C was administered tildacerfont 100 mg BID during the treatment period.
|
Period 4: Cohort D
Cohort D will begin enrollment after Cohort C has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. For Cohort D, the dose level and the frequency and timing of dosing were to be determined based on interim data from the previous cohorts, but the dose level of Cohort D was to be capped at 800 mg/day. Based on PK/PD results from Cohorts B and C, this cohort was not enrolled.
|
|---|---|---|---|---|
|
Cohort A
STARTED
|
10
|
0
|
0
|
0
|
|
Cohort A
COMPLETED
|
9
|
0
|
0
|
0
|
|
Cohort A
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Cohort B
STARTED
|
0
|
9
|
0
|
0
|
|
Cohort B
COMPLETED
|
0
|
8
|
0
|
0
|
|
Cohort B
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Cohort C
STARTED
|
0
|
0
|
7
|
0
|
|
Cohort C
COMPLETED
|
0
|
0
|
6
|
0
|
|
Cohort C
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Period 1: Cohort A
The first cohort of 9 patients underwent dose escalation through 3 dose levels of tildacerfont capsules, beginning with 200 mg QD for 2 weeks, then escalating to 600 mg QD/day for 2 weeks, then escalating to 1000 mg QD for 2 weeks with no washout between dose levels.
|
Period 2: Cohort B
Cohort B will begin enrollment after Cohort A has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort B was administered tildacerfont 200 mg BID during the treatment period.
|
Period 3: Cohort C
Cohort C will begin enrollment after Cohort B has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort C was administered tildacerfont 100 mg BID during the treatment period.
|
Period 4: Cohort D
Cohort D will begin enrollment after Cohort C has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. For Cohort D, the dose level and the frequency and timing of dosing were to be determined based on interim data from the previous cohorts, but the dose level of Cohort D was to be capped at 800 mg/day. Based on PK/PD results from Cohorts B and C, this cohort was not enrolled.
|
|---|---|---|---|---|
|
Cohort A
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Cohort B
Discontinued due to Sponsor decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Cohort A is reported separately from Cohorts B and C
Baseline characteristics by cohort
| Measure |
Cohort A
n=10 Participants
The first cohort of 9 patients underwent dose escalation through 3 dose levels of tildacerfont capsules, beginning with 200 mg QD for 2 weeks, then escalating to 600 mg QD/day for 2 weeks, then escalating to 1000 mg QD for 2 weeks with no washout between dose levels.
|
Cohort B
n=8 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort B was administered tildacerfont 200 mg BID during the treatment period.
|
Cohort C
n=6 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. Cohort C was administered tildacerfont 100 mg BID during the treatment period.
|
Cohort D
Cohort D will begin enrollment after Cohort C has been fully enrolled. Cohorts B, C, and D underwent a 2-week run-in period, a 2-week treatment period, and a 30-day washout and safety follow-up period. For Cohort D, the dose level and the frequency and timing of dosing were to be determined based on interim data from the previous cohorts, but the dose level of Cohort D was to be capped at 800 mg/day. Based on PK/PD results from Cohorts B and C, this cohort was not enrolled.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Cohort A · <=18 years
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort A · Between 18 and 65 years
|
9 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
9 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort A · >=65 years
|
1 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort B · <=18 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort B · Between 18 and 65 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
7 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
7 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort B · >=65 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort C · <=18 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort C · Between 18 and 65 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Age, Categorical
Cohort C · >=65 years
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort A · Female
|
5 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort A · Male
|
5 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort B · Female
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort B · Male
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
7 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
7 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort C · Female
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
3 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
3 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Sex: Female, Male
Cohort C · Male
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
3 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
3 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort A · Hispanic or Latino
|
3 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
3 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort A · Not Hispanic or Latino
|
7 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
7 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort A · Unknown or Not Reported
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort B · Hispanic or Latino
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
2 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
—
|
2 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort B · Not Hispanic or Latino
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
6 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
—
|
6 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort B · Unknown or Not Reported
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
—
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort C · Hispanic or Latino
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
—
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort C · Not Hispanic or Latino
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
—
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Ethnicity (NIH/OMB)
Cohort C · Unknown or Not Reported
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
—
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · American Indian or Alaska Native
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · Asian
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · Black or African American
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · White
|
10 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
10 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · More than one race
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort A · Unknown or Not Reported
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=10 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · American Indian or Alaska Native
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · Asian
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · Native Hawaiian or Other Pacific Islander
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · Black or African American
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · White
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
8 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
8 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · More than one race
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort B · Unknown or Not Reported
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=8 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · American Indian or Alaska Native
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · Asian
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · Native Hawaiian or Other Pacific Islander
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · Black or African American
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · White
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
5 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · More than one race
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
1 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Race (NIH/OMB)
Cohort C · Unknown or Not Reported
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
0 Participants
Cohort A is reported separately from Cohorts B and C
|
0 Participants
n=6 Participants • Cohort A is reported separately from Cohorts B and C
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
—
|
24 participants
n=24 Participants
|
|
Body Mass Index (kg/m^2)
|
31.7 kg/m^2
STANDARD_DEVIATION 11.80 • n=10 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 6.31 • n=8 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 5.67 • n=6 Participants
|
—
|
31.4 kg/m^2
STANDARD_DEVIATION 8.44 • n=24 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: This full analysis set includes all subjects who received at least 1 dose of study drug. The FAS was used to analyze all safety data
Incidence of treatment-emergent adverse events, changes from Baseline to End-of-study in clinical laboratory parameters, physical examination findings, vital signs, ECG parameters
Outcome measures
| Measure |
Cohort A
n=10 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort B
n=9 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001: SPR001 Capsules
|
Cohort C
n=7 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose C
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
PK Population Cohort A - Dose A (After single dose)
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|---|
|
Safety of SPR001 in Patients With CAH
|
6 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort A: Baseline/2a (Day -1-0), First dose/2b (Day 0-1), Visit 3 (Day 13-14), Visit 4 (Day 27-28), Visit 5 (Day 41-42). Cohort B and Cohort C: Visit 2 (Day 0-1), Visit 3 (Day 8), Visit 4 (Day 14-15), Visit 5 (Last dose +30d)Population: Only subjects with both baseline and post baseline (week 2) assessments were summarized. Baseline values were collected at 8am on Visit 2a (Day -1) and post-baseline Week 2 values were collected at 8a on Visit 3, Visit 4, or Visit 5. A negative change indicates improvement.
Change in 17-hydroxyprogesterone from Baseline to End-of-study. Results are expressed as mean percent change from baseline. Reductions in 17-OHP are indicators of better disease control.
Outcome measures
| Measure |
Cohort A
n=7 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort B
n=7 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001: SPR001 Capsules
|
Cohort C
n=9 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
n=7 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose C
n=8 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
PK Population Cohort A - Dose A (After single dose)
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|---|
|
Change in 17-hydroxyprogesterone
|
-47.79 percentage of mean change from baseline
Standard Deviation 63.300
|
-33.19 percentage of mean change from baseline
Standard Deviation 41.604
|
22.16 percentage of mean change from baseline
Standard Deviation 172.298
|
-23.71 percentage of mean change from baseline
Standard Deviation 64.146
|
-13.79 percentage of mean change from baseline
Standard Deviation 74.742
|
—
|
SECONDARY outcome
Timeframe: Cohort A: Visit 2a (Day -1 to 0), Visit 2b (Days 0-1), Visit 3 (Day 13-14), Visit 4 (Day 27-28), Visit 5 (Day 41 to 42). Cohorts B+C: Visit 2 (Day 0-1), Visit 3 (Day 8), Visit 4 (Day 27-28), Visit 5 (+30 days after last dose)Population: Only subjects with both baseline and post baseline (week 2) assessments were summarized. Baseline values were collected at 8am on Visit 2a (Day -1) and post-baseline Week 2 values were collected at 8a on Visit 3, Visit 4, or Visit 5.
Changes in adrenocorticotropic hormone (ACTH) and androstenedione (A4) from Baseline to End-of-study are measured in patient serum. Results are expressed as a mean percentage change from baseline. A negative change indicates improvement.
Outcome measures
| Measure |
Cohort A
n=8 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort B
n=7 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001: SPR001 Capsules
|
Cohort C
n=10 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
n=9 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose C
n=9 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
PK Population Cohort A - Dose A (After single dose)
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|---|
|
Changes in Pharmacodynamic (PD) Markers
Adrenocorticotropic hormone (ACTH)
|
-26.05 percentage of mean change from baseline
Standard Error 54.807
|
16.66 percentage of mean change from baseline
Standard Error 120.211
|
-28.53 percentage of mean change from baseline
Standard Error 53.834
|
-67.60 percentage of mean change from baseline
Standard Error 32.100
|
-36.83 percentage of mean change from baseline
Standard Error 48.510
|
—
|
|
Changes in Pharmacodynamic (PD) Markers
Androstenedione (A4)
|
-1.58 percentage of mean change from baseline
Standard Error 101.458
|
-30.17 percentage of mean change from baseline
Standard Error 35.055
|
-12.12 percentage of mean change from baseline
Standard Error 47.381
|
-33.18 percentage of mean change from baseline
Standard Error 36.465
|
-28.93 percentage of mean change from baseline
Standard Error 45.167
|
—
|
SECONDARY outcome
Timeframe: Serial PK sampling was performed at the end of the 2 weeks for all cohorts and dose levelsTo evaluate the pharmacokinetic (PK) parameter of maximum plasma concentration (Cmax) of SPR001 in patients with CAH.
Outcome measures
| Measure |
Cohort A
n=8 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort B
n=7 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001: SPR001 Capsules
|
Cohort C
n=10 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
n=10 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose C
n=9 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
PK Population Cohort A - Dose A (After single dose)
n=10 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Maximum Plasma Concentration (Cmax)
|
411.25 ng/dL
Standard Deviation 130.107
|
200.96 ng/dL
Standard Deviation 132.262
|
283.69 ng/dL
Standard Deviation 150.116
|
719.30 ng/dL
Standard Deviation 325.056
|
892.56 ng/dL
Standard Deviation 289.272
|
96.35 ng/dL
Standard Deviation 86.1
|
SECONDARY outcome
Timeframe: For Cohort A, serial blood collections were made for PK measurements on Day 1 for 200 mg SD and at Week 2 for all QD dose levels. In Cohorts B and C, serial blood samples were drawn for PK measurements at the end of the 2-week treatment period.To evaluate the PK parameter of area under the concentration-time curve (AUC) of SPR001 in patients with CAH
Outcome measures
| Measure |
Cohort A
n=8 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort B
n=7 Participants
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001: SPR001 Capsules
|
Cohort C
n=10 Participants
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
n=10 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose C
n=9 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
PK Population Cohort A - Dose A (After single dose)
n=10 Participants
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUC)
|
2975.968 ng*hr/dL
Standard Deviation 970.6
|
1425.582 ng*hr/dL
Standard Deviation 941.9188
|
1474.162 ng*hr/dL
Standard Deviation 642.6
|
4449.263 ng*hr/dL
Standard Deviation 1826.4801
|
6212.983 ng*hr/dL
Standard Deviation 2051.9077
|
421.539 ng*hr/dL
Standard Deviation 331.54
|
Adverse Events
Cohort A - Dose A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A - Dose B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A - Dose C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A - Dose A
n=10 participants at risk
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001: SPR001 Capsules
|
Cohort A - Dose B
n=10 participants at risk
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
|
Cohort A - Dose C
n=9 participants at risk；n=10 participants at risk
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
|
Cohort B
n=9 participants at risk
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A. One subject from Cohort A was allowed to enroll in Cohort B.
SPR001: SPR001 Capsules
|
Cohort C
n=7 participants at risk
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort B. One subject from Cohort A was allowed to enroll in Cohort C.
SPR001: SPR001 Capsules
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
General disorders
Hunger
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
22.2%
2/9 • Number of events 2 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
General disorders
Asthenia
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
General disorders
Chills
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
General disorders
Fatigue
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
General disorders
Feeling hot
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
20.0%
2/10 • Number of events 2 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Investigations
Blood pressure increased
|
10.0%
1/10 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
14.3%
1/7 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/10 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/9 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
11.1%
1/9 • Number of events 1 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
0.00%
0/7 • 6-week treatment period followed by a 4-week washout/safety follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place