First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215006, China
NCT Number: NCT04260373
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in Chinese healthy adult male volunteers.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Suzhou, Jiangsu, 215006, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive single dose of orally [14C]SHR4640 on Day 1.
Time frame: Up to 10 days (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled SHR4640 recovered in urine, faeces and in total, up to Day 10 (approx).
Time frame: Up to 10 days (approx) from the start of administration.
The concentrations of SHR4640 in plasma up to Day 10.
Time frame: Up to 10 days (approx) from the start of administration.
Proportion of different metabolites.
Time frame: Up to 10 days (approx) from the start of administration.
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase I Mass Balance and Biotransformation Study of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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