Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Post-operative Nausea and Vomiting
- Interventions
- Drug: 14C-APD421
- Registration Number
- NCT02881840
- Lead Sponsor
- Acacia Pharma Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14C-APD421 14C-APD421 -
- Primary Outcome Measures
Name Time Method Mass Balance 168 hours Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA Health Sciences
🇳🇱Groningen, Netherlands