Trial Outcomes & Findings for Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects (NCT NCT04802837)
NCT ID: NCT04802837
Last Updated: 2023-08-21
Results Overview
Safety was assessed using CTCAE v4.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2 participants
Primary outcome timeframe
Until study completion (Day 100)
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Ridinilazole
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole: Ridinilazole 200mg dosed BID for 10 days.
|
Vancomycin
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin: Vancomycin 125mg dosed QID for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Baseline characteristics by cohort
| Measure |
Ridinilazole
n=1 Participants
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole: Ridinilazole 200mg dosed BID for 10 days.
|
Vancomycin
n=1 Participants
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin: Vancomycin 125mg dosed QID for 10 days.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Until study completion (Day 100)Population: No analysis was done for study outcome measures due to the fact that enrollment in the clinical trial did not reach the target number of subjects needed prior to study termination and was insufficient to produce statistically reliable results.
Safety was assessed using CTCAE v4.
Outcome measures
| Measure |
Ridinilazole
n=1 Participants
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole: Ridinilazole 200mg dosed BID for 10 days.
|
Vancomycin
n=1 Participants
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin: Vancomycin 125mg dosed QID for 10 days.
|
|---|---|---|
|
Incidence and Severity of Treatment-emergant Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Ridinilazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place