ADME Study of [14C]- Larotinib in Healthy Male Subjects
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] - Larotinib in Healthy Male Participants
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] - Larotinib in Healthy Male Participants
Sponsor study identifier
interventional
6
1 country
1
Study Start
November 20, 2021
Actual (reported)Primary Completion
January 10, 2022
Actual (reported)Study Completion
January 10, 2022
Actual (reported)Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-Larotinib(Z650)in healthy male subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2021
Actual (reported)September 28, 2021
Actual (reported)November 20, 2021
Actual (reported)January 10, 2022
Actual (reported)January 10, 2022
Actual (reported)Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
up to 15 days
Identification of the Proportion of different metabolites to determine biotransformation pathway of Larotinib
Proportion of different metabolites(Larotinib and main metabolites) .
up to 15 days
Quantitive analysis of the concentrations of Larotinib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
up to 15 days
Adverse events
up to 22 days
Patients will receive single dose of \[14C\]-Larotinib (Suspension, 350mg/100μCi).
Patients will receive single dose of orally \[14C\]-Larotinib on Day 1.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Jiangsu Province Hospital
Nanjing, Jiangsu, China
liyan Miao, MD
The First Affiliated Hospital of Soochow University
6 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2021
First Posted
September 28, 2021
Study Start
November 20, 2021
Actual (reported)Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.
Contact the study team to confirm eligibility.
Primary Completion
January 10, 2022
Actual (reported)Study Completion
January 10, 2022
Actual (reported)Last Updated
March 21, 2023
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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