Phase 1
N=6
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Post-operative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02881840 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Mass Balance — 96.4 percent excreted
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 14C-APD421 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Acacia Pharma Ltd
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mass Balance |
96.4 | — |
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
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)
Data sourced from ClinicalTrials.gov (NCT02881840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.