HealthyPhase 1NCT04931524
A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777
A Phase 1 study testing carbon-14-[14C]-ANG-3777 in people with Healthy, run by Angion Biomedica Corp at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- carbon-14-[14C]-ANG-3777
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2021to Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences
Nottingham, Nottinghamshire, NG11 6JS
Sharan Sidhu, MBChB, BAO, MRCS, MFPM, +44 (0)115 974 9000, sharan.sidhu@quotientsciences.com
About this study
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
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.
- Conditions
- Healthy
- Being tested
- carbon-14-[14C]-ANG-3777
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon-14-[14C]-ANG-3777Drug
Also called Hepatocyte growth factor mimetic
Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: carbon-14-[14C]-ANG-3777 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity (TR) in all excreta urine: CumAe and Cum%Ae
Measured: 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
Measured: Day 1 to Day 8 (or Day 1 to Day 12)
Collection of plasma samples for metabolite profiling, structural identification, and quantification analysis
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 to Day 12
Determination of rates of elimination of [14C]-ANG-3777 by Ae, %Ae, CumAe and Cum%Ae by interval
Measured: Day 1 to Day 12
Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in plasma including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in urine including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of parent ANG-3777 in faeces including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax
Measured: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax
Measured: 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)
Measured: Day 1 to Day 8
Evaluation of whole blood:plasma concentration ratios for TR
Measured: Plasma from Day 1 to Day 8; whole blood up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start21 May 2021
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-randomized study. Blinding is not required.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences - Nottingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931524
- Sponsor's protocol ID
- 14C-ANG3777-HV4-102
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04931524
- Acronym / sponsor ID
- 14C-ANG3777-HV4-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 21 May 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-randomized study. Blinding is not required.
| Arm | Type | Receives |
|---|---|---|
| carbon-14-[14C]-ANG-3777 | Experimental | Drug: carbon-14-[14C]-ANG-3777Administered 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). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon-14-[14C]-ANG-3777Also: Hepatocyte growth factor mimeticArms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted | Drug | carbon-14-[14C]-ANG-3777 |
Primary outcome
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Tmax
Time frame: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in plasma including but not limited to: Cmax
Time frame: 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)
Time frame: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Tmax
Time frame: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in urine including but not limited to: Cmax
Time frame: 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)
Time frame: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Tmax
Time frame: Day 1 to Day 8
Measurement of the appropriate PK parameters of TR in faeces including but not limited to: Cmax
Time frame: 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)
Time frame: Day 1 to Day 8
Evaluation of whole blood:plasma concentration ratios for TR
Time frame: Plasma from Day 1 to Day 8; whole blood up to Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences - Nottingham, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carbon-14-[14C]-ANG-3777 in people with Healthy, run by Angion Biomedica Corp at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal Swiszcz (857-378-4175, cswiszcz@angion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.