Mass Balance and Biotransformation of [14C]HSK7653 in Human
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, single-dose, non-randomized, open-label design.
    

Detailed description: 
      Six healthy adult male subjects will be enrolled and the trial will be carried out in two
      steps:

      Step 1: Two eligible male subjects are enrolled and admitted to the clinical study site after
      passing verification against inclusion and exclusion criteria on Day -2. After being
      admitted, the subjects are trained regarding drug administration and urine and stool
      collection procedures to ensure that they are able to perform relevant operations according
      to the protocol and SOP requirements. Subjects are deprived of food for at least 10 h and of
      water for 1 h before drug administration. After oral administration of investigational
      product in the morning of Day 1 under fasted condition, each subject will be deprived of food
      for 4 h and of water for 1 h.

      Dense sampling is scheduled for all urine and stool samples excreted at specified time
      intervals within 0-336 h post-dose as well as blood samples at specified time points within
      0-336 h post-dose. Sample collection and corresponding safety monitoring will be completed in
      the morning of Day 15 (the specific time will be decided by the investigator and sponsor
      based on the phased test results, safety results, and the actual situation) before the
      subjects leave the phase I clinical trial ward. Subjects will return to the ward on Days 19,
      26, 33, and 40 to complete biological sample collection and vital sign monitoring according
      to protocol requirements. Subjects will return to the ward on Day 47 to complete the last
      biological sample collection (scheduled to be 1176 h after administration) and various
      withdrawal examinations according to protocol requirements.

      The trial employs phased testing to determine whether the dense sampling and sparse sampling
      time points should be adjusted and whether collection of blood, urine, and stool samples can
      be prematurely stopped or should be continued for an extended period based on the test
      results. If biological sampling duration exceeds 1176 h in this study, then sampling will
      continue at an interval of 7 days until the protocol-specified evaluation criteria for
      sampling termination is satisfied. Safety monitoring will continue until the date of sampling
      completion. The test results in step 1 will be used to determine whether the trial procedure
      needs to be adjusted.

      Step 2: Four eligible male subjects will be enrolled and blood, urine, and stool samples will
      be collected at specified time points/intervals. The procedures are the same as step 1.

      Criteria for sampling termination:

      Excretion: The radioactivity of biological samples (urine + stool) collected over two
      consecutive time intervals from the subject is less than 1% of the dose.

      Radioactive blood samples: Plasma radioactivity concentrations at two consecutive time points
      are < 3 times background plasma concentration.

      The target total radioactivity of biological samples (urine + stool) collected from each
      subject is not lower than 80% of the dose. The investigator should finally determine whether
      to stop sampling of a subject based on the comprehensive evaluation of radioactive test
      results, safety results and the actual situation.

      The entire trial is based on the complete test samples and data collected from 6 subjects.
      All subjects must complete the trial procedures according to the protocol requirements during
      admission in the clinical study site and they are not allowed to leave the clinical study
      site without permission by the investigator.

      Subject may withdraw from the study upon confirmation by the investigator provided that no
      clinically significant abnormality is observed in clinical observation after completion of
      the trial. Should any clinically significant abnormality be found, the subject will continue
      to stay at the study site for observation or leave the study site after comprehensive
      assessment by the investigator and periodically (usually 7 days from the last test) return to
      the hospital for retests and followed up until recovery to normal, the abnormality is not
      clinically significant, or a level deemed acceptable by the investigator.
    

Intervention name(s): [14C]HSK7653
Intervention type(s): Drug
Intervention description(s): 25 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.
Intervention model: Single Group Assignment
Intervention model description: A single-center, single-dose, non-randomized, open-label design.
Masking: None (Open Label)
Primary purpose: Treatment