Back to resultsMass-balance Study of [14C]-APD421 in Healthy Volunteers
Primary Purpose
Post-operative Nausea and Vomiting
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
14C-APD421
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Nausea and Vomiting
Eligibility Criteria
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)
Sites / Locations
- PRA Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
14C-APD421
Arm Description
Outcomes
Primary Outcome Measures
Mass Balance
Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02881840
Brief Title
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acacia Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
14C-APD421
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
14C-APD421
Primary Outcome Measure Information:
Title
Mass Balance
Description
Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
Time Frame
168 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Fox, MB BChir
Organizational Affiliation
Acacia Pharma Ltd
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31819674
Citation
Fox GM, Roffel AF, Hartstra J, Bussian LA, van Marle SP. Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers. Clin Pharmacol. 2019 Dec 2;11:161-169. doi: 10.2147/CPAA.S234256. eCollection 2019.
Results Reference
derived
Learn more about this trial
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
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