Healthy
Conditions
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.
Interventions
DRUGcarbon-14-[14C]-ANG-3777
Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted
Sponsors
Quotient Sciences
Angion Biomedica Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, non-randomized study. Blinding is not required.
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Determination of routes of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval | Day 1 to Day 12 |
| Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval | Day 1 to Day 12 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax | Day 1 to Day 8 |
| Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax | Day 1 to Day 8 |
| 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 |
| Evaluation of whole blood:plasma concentration ratios for TR | Plasma from Day 1 to Day 8; whole blood up to Day 2 |
Countries
United Kingdom
Contacts
Primary ContactChantal Swiszcz
Backup ContactMartin Robledo
Outcome results
None listed