Sponsor study identifier
interventional
6
1 country
1
Study Start
May 15, 2023
Actual (reported)Primary Completion
June 22, 2023
Actual (reported)Study Completion
November 9, 2023
Actual (reported)This trial adopts a single-center, single-dose, single-period, non-randomized, open-label study design. It is planned to enroll 6\~8 healthy male subjects, and each subject receives single oral administration of drug solution containing 600mg/approximately 100µCi \[14C\]STI-1558 under fasting conditions on trial D1. The whole blood, plasma, urine and stool samples are collected at specified time points/intervals during the trial. The pharmacokinetic parameters of the total radioactivity in plasma and whole blood, the material concentration ratios of the total radioactivity in plasma and whole blood, and the material balances are obtained by testing the total radioactivity of \[14C\]STI-1558 in plasma, whole blood, urine and feces. Meanwhile, using isotope tracer and mass spectrometry techniques, the main pathways and characteristics of metabolism and elimination of STI-1558 in humans are obtained through the quantification of radioactive metabolite profiles and the structure identification of the main metabolites in plasma, urine and feces of the subjects. The entire duration of trial is expected to be 5 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 9, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2023
Actual (reported)March 3, 2023
Actual (reported)May 15, 2023
Actual (reported)June 22, 2023
Actual (reported)November 9, 2023
Actual (reported)Distribution Ratio of the Total Radioactivity in Whole Blood and in Plasma.
To investigate the distribution ratio of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects。
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Total Radioactivity in Whole Blood and in Plasma:AUC[0-t].
To investigate the pharmacokinetic profiles of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects.
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Total Radioactivity in Whole Blood and in Plasma:Cmax .
To investigate the pharmacokinetic profiles of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects。
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Total Radioactivity in Whole Blood and in Plasma:AUC[0-inf].
To investigate the pharmacokinetic profiles of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects。
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration
Total Radioactivity in Whole Blood and in Plasma:Tmax.
To investigate the pharmacokinetic profiles of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects。
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Total Radioactivity in Whole Blood and in Plasma:t1/2.
To investigate the pharmacokinetic profiles of the total radioactivity in whole blood and plasma after oral administration of \[14C\]STI-1558 in healthy subjects。
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Total Radioactivity in the Excreta(Urine).
To perform the quantitative analysis of the total radioactivity in urine, and obtain the recovery of radioactivity and the main excretion pathways in humans after oral administration of \[14C\]STI-1558 in healthy subjects.
Urine samples collected:-24~0 hours before administration of [14C]STI-1558 and 0~8,8~24,24~48,48~72,72~96,96~120,120~144,144~168,168~192,192~216,216~240,240~264,264~288,288~312, 312~336 hours after administration.
Total Radioactivity in the Excreta(Faeces).
To perform the quantitative analysis of the total radioactivity in faeces, and obtain the recovery of radioactivity and the main excretion pathways in humans after oral administration of \[14C\]STI-1558 in healthy subjects.
Faeces samples collected:-48~0 hours before administration of [14C]STI-1558 and 0~24,24~48,48~72, 72~96,96~120,120~144,144~168,168~192,192~216, 216~240,240~264,264~288,288~312 ,312~336 hours after administration.
Plasma Concentrations of STI-1558 (active compound AC1115):AUC[0-t].
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Plasma Concentrations of STI-1558 (active compound AC1115):AUC[0-inf].
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Plasma Concentrations of STI-1558 (active compound AC1115):Cmax.
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Plasma Concentrations of STI-1558 (active compound AC1115):Tmax .
Blood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Plasma Concentrations of STI-1558 (active compound AC1115):t1/2 .
TBlood samples collected:Within 1hour before administration of [14C]STI-1558 and 0.25、0.5、1、1.5、2、 3、4、6、8、12、24、48、72、120 、168 hours after administration.
Fasting oral administration of 600 mg \[ 14C \] STI-1558 ( about 100 μCi ) solution.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing Gaobo Boren Hospital
Beijing, China
6 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2023
First Posted
March 3, 2023
Study Start
May 15, 2023
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
June 22, 2023
Actual (reported)Study Completion
November 9, 2023
Actual (reported)Last Updated
December 7, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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