Trial Outcomes & Findings for PK and Safety of SI-722 in IC/BPS (NCT NCT04208087)
NCT ID: NCT04208087
Last Updated: 2023-12-29
Results Overview
SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-12-29
Participant Flow
Participant milestones
| Measure |
Placebo
The participants received a single intravesical instillation of Placebo
|
Low Dose of SI-722
The participants received a single intravesical instillation of Low Dose of SI-722
|
Medium Dose of SI-722
The participants received a single intravesical instillation of Medium Dose of SI-722
|
Medium-high Dose of SI-722
The participants received a single intravesical instillation of Medium-high Dose of SI-722
|
High Dose of SI-722
The participants received a single intravesical instillation of High Dose of SI-722
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
The participants received a single intravesical instillation of Placebo
|
Low Dose of SI-722
The participants received a single intravesical instillation of Low Dose of SI-722
|
Medium Dose of SI-722
The participants received a single intravesical instillation of Medium Dose of SI-722
|
Medium-high Dose of SI-722
The participants received a single intravesical instillation of Medium-high Dose of SI-722
|
High Dose of SI-722
The participants received a single intravesical instillation of High Dose of SI-722
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PK and Safety of SI-722 in IC/BPS
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
The participants received a single intravesical instillation of Placebo
|
Low Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Low Dose of SI-722
|
Medium Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Medium Dose of SI-722
|
Medium-high Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Medium-high Dose of SI-722
|
High Dose of SI-722
n=7 Participants
The participants received a single intravesical instillation of High Dose of SI-722
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Body Mass Index
|
27.13 kilograms/meter square
STANDARD_DEVIATION 5.79 • n=5 Participants
|
32.52 kilograms/meter square
STANDARD_DEVIATION 4.37 • n=7 Participants
|
26.20 kilograms/meter square
STANDARD_DEVIATION 3.23 • n=5 Participants
|
23.63 kilograms/meter square
STANDARD_DEVIATION 3.39 • n=4 Participants
|
28.59 kilograms/meter square
STANDARD_DEVIATION 6.01 • n=21 Participants
|
27.61 kilograms/meter square
STANDARD_DEVIATION 5.35 • n=8 Participants
|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 16.15 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 6.40 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 14.91 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 17.79 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 11.47 • n=21 Participants
|
49.8 years
STANDARD_DEVIATION 14.16 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The PK Population is defined as all subjects who received SI-722 and who provided at least 1 evaluable PK sample. One participant in the High Dose group was excluded from PK population because the subject discontinued before IP administration due to difficulty with drawing blood.
SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.
Outcome measures
| Measure |
Low Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Low Dose of SI-722
|
Medium Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Medium Dose of SI-722
|
Medium-high Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of Medium-high Dose of SI-722
|
High Dose of SI-722
n=6 Participants
The participants received a single intravesical instillation of High Dose of SI-722
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for SI-722
|
NA ng/mL
Standard Deviation NA
Plasma PK parameters of SI-722 were not calculated because the plasma SI-722 concentrations were BLQ in all subjects.
|
NA ng/mL
Standard Deviation NA
Plasma PK parameters of SI-722 were not calculated because the plasma SI-722 concentrations were BLQ in all subjects.
|
NA ng/mL
Standard Deviation NA
Plasma PK parameters of SI-722 were not calculated because the plasma SI-722 concentrations were BLQ in all subjects.
|
NA ng/mL
Standard Deviation NA
Plasma PK parameters of SI-722 were not calculated because the plasma SI-722 concentrations were BLQ in all subjects.
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low Dose of SI-722
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medium Dose of SI-722
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medium-high Dose of SI-722
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose of SI-722
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
The participants received a single intravesical instillation of Placebo
|
Low Dose of SI-722
n=6 participants at risk
The participants received a single intravesical instillation of Low Dose of SI-722
|
Medium Dose of SI-722
n=6 participants at risk
The participants received a single intravesical instillation of Medium Dose of SI-722
|
Medium-high Dose of SI-722
n=6 participants at risk
The participants received a single intravesical instillation of Medium-high Dose of SI-722
|
High Dose of SI-722
n=6 participants at risk
The participants received a single intravesical instillation of High Dose of SI-722
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 2 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Infections and infestations
Genital herpes
|
0.00%
0/8 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
12.5%
1/8 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/8 • 4 weeks
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
0.00%
0/6 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER