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

• Sponsor: Acacia Pharma Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02881840
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-operative Nausea and Vomiting	Drug: 14C-APD421	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 14C-APD421	Drug: 14C-APD421

Outcome Measures

Primary Outcome Measures

1. Mass Balance [168 hours]

   Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Groningen		Netherlands

Sponsors and Collaborators

• Acacia Pharma Ltd

Investigators

• Study Director: Gabriel Fox, MB BChir, Acacia Pharma Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acacia Pharma Ltd
• ClinicalTrials.gov Identifier: NCT02881840
• Other Study ID Numbers: DP10020
• First Posted: Aug 29, 2016
• Last Update Posted: Jun 25, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting

Study Results

Participant Flow

Arm/Group Title	14C-APD421
Arm/Group Description	[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	14C-APD421 Amisulpride
Arm/Group Description	Single IV dose administration as an infusion over a 4 minute period
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	23 (3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Region of Enrollment (Years) [Number]
Netherlands	6

Outcome Measures

1. Primary Outcome

Title	Mass Balance
Description	Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
Time Frame	168 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	14C-APD421
Arm/Group Description	[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
Measure Participants	6
Mean (Full Range) [percent excreted]	96.4

Adverse Events

Time Frame	For the 7 day period after study drug administration
Arm/Group Title	14C-APD421
Arm/Group Description	[14C]-APD421 (amisulpride) solution for intravenous infusion (2.5 mg/mL) at 10 mg containing 1.784 MBq (48.2 μCi) 14C administered as a single IV infusion over a 4 minute period.
All Cause Mortality
	14C-APD421
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	14C-APD421
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	14C-APD421
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Ear and labyrinth disorders
Eye irritation	1/6 (16.7%)	1
Gastrointestinal disorders
Flatulence	2/6 (33.3%)	2
Nausea	1/6 (16.7%)	1
General disorders
Infusion site pain	6/6 (100%)	6
Catheter site inflammation	1/6 (16.7%)	1
Injury, poisoning and procedural complications
Wound	1/6 (16.7%)	1
Nervous system disorders
Dizziness	1/6 (16.7%)	2
Headache	1/6 (16.7%)	2
Somnolence	1/6 (16.7%)	1

Limitations/Caveats

There were no limitation or caveats in this study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.