FindTrial
Sign In

Mass-balance Study of [14C]-APD421 in Healthy Volunteers

An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02881840
Enrollment
6
Registered
2016-08-29
Start date
2016-08-31
Completion date
2016-08-31
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Nausea and Vomiting

Brief summary

Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421

Interventions

DRUG14C-APD421

Sponsors

Acacia Pharma Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy males * Age 18 to 65 years of age at time of signing informed consent * Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator * Must be willing and able to communicate and participate in the whole study * Must provide written informed consent * Must agree to use an adequate method of contraception (as defined in Section 8.4) * Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

Exclusion criteria

* Prior participation in another study with a radiation burden of \> 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of \> 1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of \> 2 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)

Design outcomes

Primary

MeasureTime frameDescription
Mass Balance168 hoursMean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421

Countries

Netherlands

Participant flow

Participants by arm

ArmCount
14C-APD421 Amisulpride
Single IV dose administration as an infusion over a 4 minute period
6
Total6

Baseline characteristics

Characteristic14C-APD421 Amisulpride
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous23 Years
STANDARD_DEVIATION 3
Region of Enrollment
Netherlands
6 Years
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 6
other
Total, other adverse events
6 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

Primary

Mass Balance

Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421

Time frame: 168 hours

ArmMeasureValue (MEAN)
14C-APD421Mass Balance96.4 percent excreted

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026