A Phase 1 Study to Investigate 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects — 8479217  

COVID-19 Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 32.8 μCi (1.21 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 feces)in 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. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• COVID-19
• Glioblastoma
• Malignant Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant
• Metastatic Melanoma
• Metastatic Pancreatic Cancer
• Myelodysplastic Syndromes
• Non-Small Cell Lung Cancer

• NCT number: NCT06469138
• Study type: Interventional
• Source: BerGenBio ASA
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2022
• Completion date: September 23, 2022