Clinical trial NCT04931524: A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2021-06-18
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-randomized study. Blinding is not required.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mass balance recovery of total radioactivity (TR) in all excreta urine: CumAe and Cum%Ae
timeFrame: Day 1 to Day 8 (or Day 1 to Day 12)
measure: Mass balance recovery of total radioactivity (TR) in all excreta faeces: CumAe and Cum%Ae
timeFrame: Day 1 to Day 8 (or Day 1 to Day 12)
measure: Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis
timeFrame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
measure: Collection of urine samples for metabolite profiling, structural identification, and quantification analysis
timeFrame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
measure: Collection of faeces samples for metabolite profiling, structural identification, and quantification analysis
timeFrame: Day 1 to Day 8, or up to Day 12 (except for metabolite profiling up to Day 2)
measure: Determination of routes of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval
timeFrame: Day 1 to Day 12
measure: Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval
timeFrame: Day 1 to Day 12
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: AUC(0-last) and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: AUC(0-last), and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: AUC(0-last), and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in plasma including but not limited to: AUC(0-last), and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in urine including but not limited to: AUC(0-last), and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax
timeFrame: Day 1 to Day 8
measure: Measurement of the appropriate PK parameters of TR in faeces including but not limited to: AUC(0-last), and AUC(0-inf)
timeFrame: Day 1 to Day 8
measure: Evaluation of whole blood:plasma concentration ratios for TR
timeFrame: Plasma from Day 1 to Day 8; whole blood up to Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
state: Nottinghamshire
Study officials:
affiliation: Quotient Sciences - Nottingham, UK
name: Sharan Sidhu, MBChB, BAO, MRCS, MFPM
role: PRINCIPAL_INVESTIGATOR
References: