NCT04931524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

May 1, 2021

Enrollment Period

11 days

First QC Date

May 28, 2021

Last Update Submit

June 11, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (26)

  • 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

Study Arms (1)

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

EXPERIMENTAL

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

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

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

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males
  • Aged 30 to 65 years inclusive at the time of signing informed consent
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2 and weighing 50 to 120 kg as measured at screening
  • Must be willing and able to communicate and participate in the whole study
  • Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
  • Must provide written informed consent
  • Must agree to adhere to the contraception requirements

You may not qualify if:

  • Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
  • Subjects who are, or are immediate family members of, a study site or sponsor employee
  • Evidence of current SARS-CoV-2 infection.
  • History of any drug or alcohol abuse in the past 2 years
  • 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)
  • A confirmed positive alcohol breath test at screening or admission
  • 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
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

RECRUITING

Study Officials

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM

    Quotient Sciences - Nottingham, UK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Swiszcz

CONTACT

857-378-4175cswiszcz@angion.com

Martin Robledo

CONTACT

857-378-4173mrobledo@angion.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, non-randomized study. Blinding is not required.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 18, 2021

Study Start

May 21, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 18, 2021

Record last verified: 2021-05

Locations

GB(1)