Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469138
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-17
Brief Title:
A Phase 1 Study to Investigate 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects
Sponsor:
BerGenBio ASA
Organization:
BerGenBio ASA
Study Overview
Official Title:
A Phase 1 Open-label Nonrandomized Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-06
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:
8479217
Brief Summary:
The aims of this Study are to determine
How much of the Study Drug bemcentinib ends up in urine and faeces
How much of the Study Drug and its breakdown products get into the bloodstream
The breakdown products metabolites of the Study Drug
The safety of the Study Drug and any side effects that might be associated with it
How much of the Study Drug bemcentinib ends up in urine and faeces
How much of the Study Drug and its breakdown products get into the bloodstream
The breakdown products metabolites of the Study Drug
The safety of the Study Drug and any side effects that might be associated with it
Detailed Description:
This will be a Phase 1 open-label nonrandomized single oral dose study in up to 8 healthy male subjects with 6 required to complete the study
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to dose administration Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study Subjects will be admitted into the study site on Day -1 On the morning of Day 1 all subjects will receive a single oral dose of 200 mg containing approximately 328 μCi 121 MBq of 14C-bemcentinib 30 minutes after starting a standard high-fat breakfast
Subjects will be confined to the study site until at least Day 8 Subjects will be discharged from the study site on Day 8 if the following discharge criteria are met
90 mass balance recovery and
1 of the total radioactive dose is recovered in combined excreta urine and fecesin 2 consecutive 24-hour periods
If these discharge criteria are not met by Day 8 subjects will be required to remain resident until discharge criteria are met up to Day 15 If criteria are not met by Day 15 subjects may be asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and fecal excretion If needed the 2 additional 24-hour nonresidential collections will start on the morning of Days 22 and 29 to be brought into the study site at the end of the collection interval on Days 23 and 30 respectively If on the second occasion the subject has still not met the desired criterion then the subject will be discharged from the study per investigator and sponsor decision
Subjects experiencing emesis during the first 4 hours post-dose may be discharged on the same day from the study site provided there are no safety concerns and after discharge study procedures are performed
The total duration of study participation for each subject from screening to outpatient visit if required is anticipated to be a maximum of approximately 58 days
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to dose administration Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study Subjects will be admitted into the study site on Day -1 On the morning of Day 1 all subjects will receive a single oral dose of 200 mg containing approximately 328 μCi 121 MBq of 14C-bemcentinib 30 minutes after starting a standard high-fat breakfast
Subjects will be confined to the study site until at least Day 8 Subjects will be discharged from the study site on Day 8 if the following discharge criteria are met
90 mass balance recovery and
1 of the total radioactive dose is recovered in combined excreta urine and fecesin 2 consecutive 24-hour periods
If these discharge criteria are not met by Day 8 subjects will be required to remain resident until discharge criteria are met up to Day 15 If criteria are not met by Day 15 subjects may be asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and fecal excretion If needed the 2 additional 24-hour nonresidential collections will start on the morning of Days 22 and 29 to be brought into the study site at the end of the collection interval on Days 23 and 30 respectively If on the second occasion the subject has still not met the desired criterion then the subject will be discharged from the study per investigator and sponsor decision
Subjects experiencing emesis during the first 4 hours post-dose may be discharged on the same day from the study site provided there are no safety concerns and after discharge study procedures are performed
The total duration of study participation for each subject from screening to outpatient visit if required is anticipated to be a maximum of approximately 58 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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