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

Angion Biomedica Corp6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

carbon-14-[14C]-ANG-3777DRUG

Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Sciences

Nottingham, Nottinghamshire, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Mass balance recovery of total radioactivity (TR) in all excreta urine: CumAe and Cum%Ae

Time frame: Day 1 to Day 8 (or Day 1 to Day 12)

Mass balance recovery of total radioactivity (TR) in all excreta faeces: CumAe and Cum%Ae

Time frame: Day 1 to Day 8 (or Day 1 to Day 12)

Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis

Time frame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)

Collection of urine samples for metabolite profiling, structural identification, and quantification analysis

Time frame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)

Collection of faeces samples for metabolite profiling, structural identification, and quantification analysis

Time frame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)

Determination of routes of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval

Time frame: Day 1 to Day 12

Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval

Time frame: Day 1 to Day 12

Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax

Time frame: Day 1 to Day 8

Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax

Time frame: Day 1 to Day 8

Central Contacts

Chantal Swiszcz

CONTACT

857-378-4175 cswiszcz@angion.com

Martin Robledo

CONTACT

857-378-4173 mrobledo@angion.com

Data from ClinicalTrials.gov

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