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

Acacia Pharma

Status and phase: Completed; Phase 1

Conditions: Post-operative Nausea and Vomiting

Treatments: Drug: 14C-APD421

Study type: Interventional

Funder types: Industry

Identifiers

NCT02881840

DP10020

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

14C-APD421

Experimental group

Treatment:

Drug: 14C-APD421