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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon-14-[14C]-ANG-3777 | Drug | Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantal Swiszcz | Contact | 857-378-4175 | cswiszcz@angion.com | |
| Martin Robledo | Contact | 857-378-4173 | mrobledo@angion.com |
| Name | Affiliation | Role |
|---|---|---|
| Sharan Sidhu, MBChB, BAO, MRCS, MFPM | Quotient Sciences - Nottingham, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Recruiting | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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Open-label, non-randomized study. Blinding is not required.
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| 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 |