A Phase 1 Study to Investigate 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects
NCT Number: NCT06469138
Acronym: 8479217
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non-Small Cell Lung Cancer|Metastatic Melanoma|Acute Myeloid Leukemia|Myelodysplastic Syndromes|Metastatic Pancreatic Cancer|Glioblastoma|Malignant Mesothelioma|COVID-19
Interventions: DRUG: Bemcentinib
Sponsor: BerGenBio ASA
Sex: MALE
Age: ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-02
Completion Date: 2022-09-23
Locations: Labcorp Clinical Research Unit Ltd., Leeds, LS2 9LH, United Kingdom

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.

Primary Outcome Measures: Total Radioactivity Recovery (fet1-t2) - Urine, This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity recovery in urine (based upon urine samples collected at set timepoints during the study)., Samples collected over a 5-week period: Days 1 - 8: Predose (-3 to 0 hours), over 12-24 hour intervals up to 168 hours post-dose, Days 8-15: over 24 hour intervals up to 336 hours post-dose and 24 hour intervals between Days 22-23 & 29-30.|Total Radioactivity Recovery (fet1-t2) - Faeces, This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity recovery in faeces (based upon faeces samples collected at set timepoints during the study)., Samples collected over a 5-week period: Days 1 - 8: Predose (from check in to 0 hours), over 12-24 hour intervals up to 168 hours post-dose, Days 8-15: over 24 hour intervals up to 336 hours post-dose and 24 hour intervals between Days 22-23 & 29-30.|Total Radioactivity - Plasma, This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in plasma (based upon plasma samples collected at set timepoints during the study)., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Total Radioactivity - Whole Blood, This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in whole blood (based upon whole blood samples collected at set timepoints during the study)., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Plasma Pharmacokinetic Parameters - Maximum observed concentration (Cmax), Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of 14C-bemcentinib in plasma., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Plasma Pharmacokinetic Parameters - Time to Maximum Observed Concentration (Tmax), Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of 14C-bemcentinib in plasma., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Plasma Pharmacokinetic Parameters - Terminal Elimination Half-life (t1/2), Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of 14C-bemcentinib in plasma., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Plasma Pharmacokinetic Parameters - Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) of 14C-bemcentinib in plasma., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Plasma Pharmacokinetic Parameters - Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast), Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of 14C-bemcentinib in plasma., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Urinary Recovery - Percentage of the dose administered recovered over the time interval t1 to t2 (fet1-t2), This endpoint will report the relevant data for the parameters assessed in order to measure urinary recovery (based upon urine samples collected at set timepoints during the study)., Samples collected over a 5-week period: Days 1 - 8: Predose (-3 to 0 hours), over 12-24 hour intervals up to 168 hours post-dose, Days 8-15: over 24 hour intervals up to 336 hours post-dose and 24 hour intervals between Days 22-23 & 29-30.
Secondary Outcome Measures: Metabolic Profile & Identification - Bemcentinib - Plasma, This endpoint will report the relevant data for the parameters assessed in order to measure the metabolic profile of 14C-bemcentinib in plasma (based upon plasma samples collected at set timepoints during the study)., Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose|Metabolic Profile & Identification - Bemcentinib - Urine, This endpoint will report the relevant data for the parameters assessed in order to measure the metabolic profile of 14C-bemcentinib in urine (based upon urine samples collected at set timepoints during the study)., Samples collected over a 5-week period as follows: Days 1 - 8: Predose (-3 to 0 hours), over 12-24 hour intervals up to 168 hours post-dose, Days 8-15: over 24 hour intervals up to 336 hours post-dose and 24 hour intervals between Days 22-23 & 29-30.|Metabolic Profile & Identification - Bemcentinib - Faeces, This endpoint will report the relevant data for the parameters assessed in order to measure the metabolic profile of 14C-bemcentinib in faeces (based upon faeces samples collected at set timepoints during the study)., Samples collected over a 5-week period as follows: Days 1 - 8: Predose (-3 to 0 hours), over 12-24 hour intervals up to 168 hours post-dose, Days 8-15: over 24 hour intervals up to 336 hours post-dose and 24 hour intervals between Days 22-23 & 29-30.|Adverse Events, This secondary endpoint relates to the number of participants who report an adverse event (AE) during the study., Collection of AEs occurs through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).|Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to study completion., This primary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study., From Day 1 to study completion (up to 5 weeks)|Number of participants who report a change from normal range values for any of the associated 12-Lead ECG Parameters from first dose on Day 1 to study completion., This primary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the 12-Lead ECG parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study., From Day 1 to study completion (up to 5 weeks)|Number of participants who report a change from normal range values for any of the vital signs parameters from first dose on Day 1 to study completion., This primary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the vital signs parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study., From Day 1 to study completion (up to 5 weeks)|Number of participants who report a change from normal with respect to physical examination parameters from first dose on Day 1 to study completion., This primary endpoint will report the number of participants who record a change which is deemed as outside of normal range (clinically significant changes only) for any of the physical examination parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study., From Day 1 to study completion (up to 5 weeks)