A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777

Healthy Clinical Trial

Official title:

An Open Label, Single-Dose Study to Assess the Mass Balance Recovery, Metabolism and Excretion of [14C] ANG 3777 in Healthy Male Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931524
• Other study ID #: 14C-ANG3777-HV4-102
• Status: Recruiting
• Phase: Phase 1
• Start date: May 21, 2021
• Est. completion date: June 2021

Study information

• Verified date: May 2021
• Source: Angion Biomedica Corp
• Contact: Chantal Swiszcz
• Phone: 857-378-4175
• Email: cswiszcz[@]angion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy males

2. Aged 30 to 65 years inclusive at the time of signing informed consent

3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 and weighing 50 to 120 kg as measured at screening

4. Must be willing and able to communicate and participate in the whole study

5. Must have regular bowel movements (ie average stool production of =1 and =3 stools per day)

6. Must provide written informed consent

7. Must agree to adhere to the contraception requirements

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1

2. Subjects who are, or are immediate family members of, a study site or sponsor employee

3. Evidence of current SARS-CoV-2 infection.

4. History of any drug or alcohol abuse in the past 2 years

5. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)

6. A confirmed positive alcohol breath test at screening or admission

7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission

8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• carbon-14-[14C]-ANG-3777
Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Angion Biomedica Corp	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance recovery of total radioactivity (TR) in all excreta urine: CumAe and Cum%Ae		Day 1 to Day 8 (or Day 1 to Day 12)
Primary	Mass balance recovery of total radioactivity (TR) in all excreta faeces: CumAe and Cum%Ae		Day 1 to Day 8 (or Day 1 to Day 12)
Primary	Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis		Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Primary	Collection of urine samples for metabolite profiling, structural identification, and quantification analysis		Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Primary	Collection of faeces samples for metabolite profiling, structural identification, and quantification analysis		Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
Primary	Determination of routes of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval		Day 1 to Day 12
Primary	Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval		Day 1 to Day 12
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: AUC(0-last) and AUC(0-inf)		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: AUC(0-last), and AUC(0-inf)		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: AUC(0-last), and AUC(0-inf)		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in plasma including but not limited to: AUC(0-last), and AUC(0-inf)		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in urine including but not limited to: AUC(0-last), and AUC(0-inf)		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax		Day 1 to Day 8
Primary	Measurement of the appropriate PK parameters of TR in faeces including but not limited to: AUC(0-last), and AUC(0-inf)		Day 1 to Day 8
Primary	Evaluation of whole blood:plasma concentration ratios for TR		Plasma from Day 1 to Day 8; whole blood up to Day 2