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NCT06469138 · OUTCOME

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.

A Study to Investigate 14C-bemcentinib in Healthy Male Subjects · Source last updated 2025-01-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 to study completion (up to 5 weeks)

What was measured

This secondary 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.

Groups in this outcome

Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib

This was the only treatment arm in the study. Up to 8 participants were to 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. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
This secondary 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.
groups
  1. description
    This was the only treatment arm in the study. Up to 8 participants were to 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. Bemcentinib: Each 200 mg dose contained approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and was administered as a single dose on Day 1 of the study.
    id
    OG000
    title
    Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From Day 1 to study completion (up to 5 weeks)
title
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.
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice