Trial Outcomes & Findings for A Study to Investigate 14C-bemcentinib in Healthy Male Subjects (NCT NCT06469138)
NCT ID: NCT06469138
Last Updated: 2025-01-29
Results Overview
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). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
COMPLETED
PHASE1
6 participants
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
2025-01-29
Participant Flow
Study recruitment was undertaken in the United Kingdom at a single site. The recruitment process began in August 2022 and concluded in September 2022. A sufficient number of volunteers were screened in order to successfully recruit 6 eligible participants.
Participants were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed Consent, Demographics, Medical History, Height \& Weight, ECG, Vital Signs and Safety Laboratory Testing/Urinalysis \& Drugs of Abuse testing.
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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42.2 Years
STANDARD_DEVIATION 4.40 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United Kingdom
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6 participants
n=5 Participants
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Height
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172.30 Centimetres
STANDARD_DEVIATION 6.508 • n=5 Participants
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Weight
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80.58 Kilograms
STANDARD_DEVIATION 7.066 • n=5 Participants
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Body Mass Index
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27.15 kg/m^2
STANDARD_DEVIATION 1.952 • n=5 Participants
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PRIMARY outcome
Timeframe: 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-doseThis 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). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Total Radioactivity - Plasma Maximum Observed Concentration (Cmax)
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81.2 ngEq/mL
Geometric Coefficient of Variation 26.8
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PRIMARY outcome
Timeframe: 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-doseThis 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). Analysis was derived from obtaining whole blood samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Total Radioactivity - Whole Blood Maximum Observed Concentration (Cmax)
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121 ngEq/mL
Geometric Coefficient of Variation 21.6
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PRIMARY outcome
Timeframe: 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-dosePlasma 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. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Plasma Pharmacokinetic Parameters Bemcentinib - Maximum Observed Concentration (Cmax)
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55.8 ng/mL
Geometric Coefficient of Variation 23.5
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PRIMARY outcome
Timeframe: 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-dosePlasma 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. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Plasma Pharmacokinetic Parameters Bemcentinib - Time to Maximum Observed Concentration (Tmax)
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12.0 Hour
Interval 12.0 to 36.0
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PRIMARY outcome
Timeframe: 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-dosePlasma 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. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Plasma Pharmacokinetic Parameters Bemcentinib - Terminal Elimination Half-life (t1/2)
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92.0 Hour
Geometric Coefficient of Variation 5.3
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PRIMARY outcome
Timeframe: 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-dosePlasma 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. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
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6050 h*ng/mL
Geometric Coefficient of Variation 12.3
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PRIMARY outcome
Timeframe: 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-dosePlasma 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. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
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5550 h*ng/mL
Geometric Coefficient of Variation 13.3
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SECONDARY outcome
Timeframe: 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).This secondary endpoint relates to the number of participants who report an adverse event (AE) during the study.
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Number of Participants With Adverse Events
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3 Participants
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SECONDARY outcome
Timeframe: From Day 1 to study completion (up to 5 weeks)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.
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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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.
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0 Participants
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SECONDARY outcome
Timeframe: From Day 1 to study completion (up to 5 weeks)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 12-Lead ECG parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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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.
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0 Participants
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SECONDARY outcome
Timeframe: From Day 1 to study completion (up to 5 weeks)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 vital signs parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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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.
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0 Participants
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SECONDARY outcome
Timeframe: From Day 1 to study completion (up to 5 weeks)This secondary 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.
Outcome measures
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 Participants
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.
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Number of Participants Who Report a Change From Normal With Respect to Physical Examination Parameters From First Dose on Day 1 to Study Completion.
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0 Participants
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Adverse Events
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Dose Cohort - 200 mg Containing Approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib
n=6 participants at risk
This is the only treatment arm in this study. Up to 8 participants 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.
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.
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Nervous system disorders
Headache
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16.7%
1/6 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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General disorders
Bruising Right Antecubital Fossa (Venepuncture Related)
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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Gastrointestinal disorders
Loose Stool
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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General disorders
Bruising to Left Antecubital Fossa (Venepuncture Related)
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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Infections and infestations
COVID-19
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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Respiratory, thoracic and mediastinal disorders
Sore Throat
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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Skin and subcutaneous tissue disorders
Night Sweats
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16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place