Trial Outcomes & Findings for Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects (NCT NCT05737433)
NCT ID: NCT05737433
Last Updated: 2024-10-03
Results Overview
Cumulative percentage of total radioactivity recovered after a single oral dose of \[14C\]-rencofilstat.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
6 participants
Primary outcome timeframe
22 Days
Results posted on
2024-10-03
Participant Flow
After subjects consented for study, they went through the screening process. Subjects that qualified for study were assigned to the single treatment arm.
Participant milestones
| Measure |
[14C]-RCF 225mg
\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
[14C]-RCF 225mg
n=6 Participants
\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose
\[14C\]-rencofilstat 225mg: radio-labelled 225mg oral dose of rencofilstat
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
|
% of [14C]-RCF recovered
|
0 %
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 DaysPopulation: Mass balance population
Cumulative percentage of total radioactivity recovered after a single oral dose of \[14C\]-rencofilstat.
Outcome measures
| Measure |
[14C]-RCF 225mg
n=6 Participants
\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose
|
|---|---|
|
To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat
|
91 percentage of total radioactivity
|
Adverse Events
[14C]-RCF 225mg
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 |
[14C]-RCF 225mg
n=6 participants at risk
\[14C\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • 63 days, screening period to on study last visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • 63 days, screening period to on study last visit.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 63 days, screening period to on study last visit.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 63 days, screening period to on study last visit.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Number of events 1 • 63 days, screening period to on study last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • 63 days, screening period to on study last visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place