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

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

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 Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: carbon-14-[14C]-ANG-3777

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
      • Recruiting
      • Quotient Sciences
      • Contact: Sharan Sidhu, MBChB, BAO, MRCS, MFPM; Phone Number: +44 (0)115 974 9000; Email: sharan.sidhu@quotientsciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted; Other Names: Hepatocyte growth factor mimetic

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Angion Biomedica Corp
• Collaborators: Quotient Sciences
• Investigators: Principal Investigator: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences - Nottingham, UK

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2021
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (ACTUAL): June 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 14C-ANG3777-HV4-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes