Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 6:36 PM
Study NCT ID:
NCT05074134
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2021-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absorption, Metabolism, and Excretion Study of [14C]-TNP-2092
Sponsor:
TenNor Therapeutics Limited
Organization:
Study Overview
Official Title:
An Open Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-TNP-2092 Following a Single Intravenous Dose Administration
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered \[14C\]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi \[14C\]-TNP-2092 administered over 60 minutes (±10 minutes).
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi \[14C\]-TNP-2092 administered over 60 minutes (±10 minutes).
Detailed Description:
This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered \[14C\]-TNP-2092 Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day 1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 µCi \[14C\]-TNP-2092 administered over 60 minutes (±10 minutes).
Subjects will remain in the unit for 7 days after dosing (until morning of Day 8) for observation and collection of whole blood, urine and fecal samples.
Whole blood samples will be collected at pre-dose (-30 minutes) and at 15 minutes, 30 minutes, 45 minutes, 1 h (end of infusion), and at 1 h 5 minutes, 1 h 10 minutes, 1 h 15 minutes, 1 h 30 minutes, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after initiation of the \[14C\]-TNP-2092 infusion (n=25 timepoints per subject). Depending on 14C radiolabel recovery, an additional whole blood sample may be collected on Day 15 (336 hours after initiation dosing) for a total of n=26 timepoints per subject. These samples will be used to determine concentrations of TNP-2092 (in plasma), metabolite profiling (in plasma), and total \[14C\] (whole blood and plasma).
Urine will be continuously collected for \[14C\] recovery, and metabolite assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-8, 8-16, 16-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the \[14C\]-TNP 2092 infusion (n=10 timepoints per subject). Depending on 14C radiolabel recovery, additional urine samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Feces will be continuously collected for metabolite and \[14C\] recovery assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the \[14C\]-TNP-2092 infusion (n=8 timepoints per subject). Depending on 14C radiolabel recovery, additional fecal samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Safety will be assessed by physical examination, vital signs (VS), 12-lead electrocardiograms, clinical laboratory tests (serum chemistry panel, hematology, coagulation, and urinalysis), use of concomitant medications, collection of adverse events, and by unscheduled assessments as needed for management of adverse events.
Subjects will be discharged from the CPC on Day 8 after completion of all 168h timepoint assessments. The Investigator will indicate whether ≥90% of the 14C radiolabel has been recovered in samples collected through 168h; if so, Day 8 will be the final study visit. If recovery of 14C in excreta is \<90% by the time of discharge on Day 8, subjects will return to the site for an additional 24-hour PK confinement period on Days 14-15 (312-336h). The date of study completion for each subject will be defined as the last day that PK samples are collected. To avoid enrolling a participant with systemic 14C excess, samples of urine and/or blood (either whole blood or plasma) obtained at Screening must show no significant excess of 14C over environmental background level.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day 1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 µCi \[14C\]-TNP-2092 administered over 60 minutes (±10 minutes).
Subjects will remain in the unit for 7 days after dosing (until morning of Day 8) for observation and collection of whole blood, urine and fecal samples.
Whole blood samples will be collected at pre-dose (-30 minutes) and at 15 minutes, 30 minutes, 45 minutes, 1 h (end of infusion), and at 1 h 5 minutes, 1 h 10 minutes, 1 h 15 minutes, 1 h 30 minutes, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after initiation of the \[14C\]-TNP-2092 infusion (n=25 timepoints per subject). Depending on 14C radiolabel recovery, an additional whole blood sample may be collected on Day 15 (336 hours after initiation dosing) for a total of n=26 timepoints per subject. These samples will be used to determine concentrations of TNP-2092 (in plasma), metabolite profiling (in plasma), and total \[14C\] (whole blood and plasma).
Urine will be continuously collected for \[14C\] recovery, and metabolite assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-8, 8-16, 16-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the \[14C\]-TNP 2092 infusion (n=10 timepoints per subject). Depending on 14C radiolabel recovery, additional urine samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Feces will be continuously collected for metabolite and \[14C\] recovery assessments from the time of admission until immediately prior to dosing (pre dose) and over the following collection intervals: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours (Day 8) after initiation of the \[14C\]-TNP-2092 infusion (n=8 timepoints per subject). Depending on 14C radiolabel recovery, additional fecal samples may be collected on Days 14 and 15 (312-336 hours after dosing).
Safety will be assessed by physical examination, vital signs (VS), 12-lead electrocardiograms, clinical laboratory tests (serum chemistry panel, hematology, coagulation, and urinalysis), use of concomitant medications, collection of adverse events, and by unscheduled assessments as needed for management of adverse events.
Subjects will be discharged from the CPC on Day 8 after completion of all 168h timepoint assessments. The Investigator will indicate whether ≥90% of the 14C radiolabel has been recovered in samples collected through 168h; if so, Day 8 will be the final study visit. If recovery of 14C in excreta is \<90% by the time of discharge on Day 8, subjects will return to the site for an additional 24-hour PK confinement period on Days 14-15 (312-336h). The date of study completion for each subject will be defined as the last day that PK samples are collected. To avoid enrolling a participant with systemic 14C excess, samples of urine and/or blood (either whole blood or plasma) obtained at Screening must show no significant excess of 14C over environmental background level.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: