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

Post-operative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881840
• Other study ID #: DP10020
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: August 2016

Study information

• Verified date: June 2019
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post-operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• 14C-APD421

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass Balance	Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421	168 hours