Trial Outcomes & Findings for Mass-balance Study of [14C]-APD421 in Healthy Volunteers (NCT NCT02881840)
NCT ID: NCT02881840
Last Updated: 2019-06-25
Results Overview
Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
168 hours
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
14C-APD421
\[14C\]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
14C-APD421 Amisulpride
n=6 Participants
Single IV dose administration as an infusion over a 4 minute period
|
|---|---|
|
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
|
|
Age, Continuous
|
23 Years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 Years
n=5 Participants
|
PRIMARY outcome
Timeframe: 168 hoursMean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
Outcome measures
| Measure |
14C-APD421
n=6 Participants
\[14C\]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
|
|---|---|
|
Mass Balance
|
96.4 percent excreted
Interval 92.0 to 98.5
|
Adverse Events
14C-APD421
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
14C-APD421
n=6 participants at risk
\[14C\]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
|
|---|---|
|
General disorders
Infusion site pain
|
100.0%
6/6 • Number of events 6 • For the 7 day period after study drug administration
|
|
Ear and labyrinth disorders
Eye irritation
|
16.7%
1/6 • Number of events 1 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
2/6 • Number of events 2 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • For the 7 day period after study drug administration
|
|
General disorders
Catheter site inflammation
|
16.7%
1/6 • Number of events 1 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Wound
|
16.7%
1/6 • Number of events 1 • For the 7 day period after study drug administration
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 2 • For the 7 day period after study drug administration
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • For the 7 day period after study drug administration
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • For the 7 day period after study drug administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place