PRA International
Zuidlaren, 9471GP, Netherlands
NCT Number: NCT01911715
A study to investigate the excretion routes of radio-labelled MDV3100.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Zuidlaren, 9471GP, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral
Other names: Xtandi, enzalutamide
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time to attain Cmax (tmax)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (21 times)
Time frame: Day 1 through Day 78 (17 times)
Time frame: Day 1 through Day 78 (16 times)
Time frame: Day 1 through Day 78 (17 times for urine and 16 times for feces)
Time frame: Day 1 through Day 78 (17 times for urine and 16 times for feces)
Time frame: Day 1 through Day 78 (21 times)
PK of MDV3100, MDPC0001, and MDPC0002 in plasma based on validated LC-MS/MS methods:
The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated
Time frame: Day 1 through Day 78 (17 times)
PK of MDV3100, MDPC0001, and MDPC0002 in urine based on validated LC-MS/MS methods:
The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated
Time frame: Day 1 through Day 78 (14 times)
Identification and possible quantification of metabolites in plasma, and if applicable, in urine and feces
Time frame: Day 1 through Day 78
Astellas Pharma Europe B.V.
Industry
A Phase I Open-label Study to Investigate the Mass Balance and Biotransformation of a Single Oral 160 mg (100 µCi) Dose of 14C-MDV3100 (ASP9785) in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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