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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acacia Pharma Ltd

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)