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
1 other identifier
interventional
6
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedResults Posted
Study results publicly available
June 7, 2019
CompletedJune 25, 2019
June 1, 2019
Same day
August 1, 2016
March 7, 2019
June 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mass Balance
Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
168 hours
Study Arms (1)
14C-APD421
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Groningen, Netherlands
Related Publications (1)
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.
PMID: 31819674DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There were no limitation or caveats in this study.
Results Point of Contact
- Title
- Dr Gabriel Fox
- Organization
- Acacia Pharma Ltd
Study Officials
- STUDY DIRECTOR
Gabriel Fox, MB BChir
Acacia Pharma Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 29, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 25, 2019
Results First Posted
June 7, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share