Trials / Completed

CompletedNCT06469138

A Study to Investigate 14C-bemcentinib in Healthy Male Subjects

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
Phase: Phase 1
Study type: Interventional
Enrollment: 6 (actual)

Sponsor: BerGenBio ASA · Industry
Sex: Male
Age: 35 Years – 55 Years
Healthy volunteers: Accepted

Summary

The aims of this Study were 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.

Detailed description

This was 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 were screened to assess their eligibility to enter the study within 28 days prior to dose administration. Up to 8 subjects were enrolled to ensure that 6 subjects completed the study. Subjects were admitted into the study site on Day -1. On the morning of Day 1, all subjects received 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 were confined to the study site until at least Day 8. Subjects were discharged from the study site on Day 8 if the following discharge criteria were 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 were not met by Day 8, subjects were required to remain resident until discharge criteria are met, up to Day 15. If criteria were not met by Day 15, subjects were 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 started 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 still did not meet the desired criterion, then the subject was discharged from the study, per investigator and sponsor decision. Subjects experiencing emesis during the first 4 hours post-dose were discharged on the same day from the study site, provided there were no safety concerns, and after discharge study procedures were performed. The total duration of study participation for each subject (from screening to outpatient visit \[if required\]) was anticipated to be a maximum of approximately 58 days.

Conditions

Interventions

Type	Name	Description
DRUG	Bemcentinib	Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study.

Timeline

Start date: 2022-08-02
Primary completion: 2022-09-23
Completion: 2022-09-23
First posted: 2024-06-21
Last updated: 2025-01-29
Results posted: 2025-01-29

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06469138. Inclusion in this directory is not an endorsement.