Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05074134
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2021-09-29
Brief Title:
Absorption Metabolism and Excretion Study of 14C-TNP-2092
Sponsor:
TenNor Therapeutics Limited
Organization:
TenNor Therapeutics Inc
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 mg3 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 mg3 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 mg3 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 n25 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 n26 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 n10 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 n8 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 andor 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 mg3 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 n25 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 n26 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 n10 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 n8 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 andor 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:
None
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?:
None