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Status unknownNCT04931524Updated Jun 18, 2021

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

A Phase 1 interventional study of carbon-14-[14C]-ANG-3777 in Healthy, sponsored by Angion Biomedica Corp. Status unknown at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by Angion Biomedica Corp · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Angion Biomedica Corp is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy males
  2. Aged 30 to 65 years inclusive at the time of signing
  3. (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 requirements

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    carbon-14-[14C]-ANG-3777

    Administered IV as a single dose over 30 minutes on the morning of Day 1 following an 8 hour overnight fast and remain in the clinical unit until up to 168 hours after dosing (to Day 8). If mass balance criteria have not been met on Day 8, the clinical unit residency may be extended up to an additional 96 hours (to Day 12).

    Drug: carbon-14-[14C]-ANG-3777

Interventions

  • Drugcarbon-14-[14C]-ANG-3777

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

    Also known as: Hepatocyte growth factor mimetic

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: AUC(0-last) and AUC(0-inf)

    Time frame: Day 1 to Day 8

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

    Time frame: Day 1 to Day 8

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

    Time frame: Day 1 to Day 8

  13. Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: AUC(0-last), and AUC(0-inf)

    Time frame: Day 1 to Day 8

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

    Time frame: Day 1 to Day 8

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

    Time frame: Day 1 to Day 8

  16. Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: AUC(0-last), and AUC(0-inf)

    Time frame: Day 1 to Day 8

  17. Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax

    Time frame: Day 1 to Day 8

  18. Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax

    Time frame: Day 1 to Day 8

  19. Measurement of the appropriate PK parameters of TR in plasma including but not limited to: AUC(0-last), and AUC(0-inf)

    Time frame: Day 1 to Day 8

  20. Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax

    Time frame: Day 1 to Day 8

  21. Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax

    Time frame: Day 1 to Day 8

  22. Measurement of the appropriate PK parameters of TR in urine including but not limited to: AUC(0-last), and AUC(0-inf)

    Time frame: Day 1 to Day 8

  23. Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax

    Time frame: Day 1 to Day 8

  24. Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax

    Time frame: Day 1 to Day 8

  25. Measurement of the appropriate PK parameters of TR in faeces including but not limited to: AUC(0-last), and AUC(0-inf)

    Time frame: Day 1 to Day 8

  26. Evaluation of whole blood:plasma concentration ratios for TR

    Time frame: Plasma from Day 1 to Day 8; whole blood up to Day 2

07

Study locations

1 of 1 sites recruiting
  • Quotient Sciences
    Nottingham, Nottinghamshire NG11 6JS, United Kingdom
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for Jun 2021, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2021
First posted
Jun 18, 2021
StartActual
May 21, 2021
Primary completionEst.
Jun 2021
CompletionEst.
Jun 2021
Last update
Jun 18, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04931524
Lead sponsor
Angion Biomedica Corp
Collaborators
Quotient Sciences
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
May 21, 2021
Primary completion
Jun 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Jun 18, 2021

Study contacts

Chantal Swiszcz
Contact
cswiszcz@angion.com
857-378-4175
Martin Robledo
Contact
mrobledo@angion.com
857-378-4173
Sharan Sidhu, MBChB, BAO, MRCS, MFPM
principal investigator · Quotient Sciences - Nottingham, UK

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Carbon-14

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