Influence of Race/Ethnic Origin on the breakdown/elimination of SCH 527123 in the body.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: Part 1: SCH 527123 10mg, 30mg, 50mg single oral dose on Day 1 (Each subject receives all 3 doses in a randomised sequence, separated by at least 7 days before progressing to part 2 of the study). Part 2: SCH 527123 10mg or 50mg daily for 7 days (Randomised to receive one or the other dose level) CONDITION: The Influence of race and ethnic origin on the pharmacokinetics of SCH 527123. PRIMARY OUTCOME: To determine the influence of race and ethnic origin on the pharmacokinetics of SCH 527123. ; (Assessed through comparison of pharmacokinetic (PK) data from blood samples between Japanese, Chinese and Caucasian subjects) SECONDARY OUTCOME: To evaluate the pharmacodynamics, safety & tolerability of SCH 527123 in Healthy Subjects. (Assessed via peripheral blood neutrophil counts and Flourescence‐Activated Cell Sorter (FACS) analysis & routine laboratory safety tests (haematology/chemistry & urinalysis)). INCLUSION CRITERIA: Parts 1 & 2 ‐ Male/Female Healthy volunteers (must be Caucasian, Japanese or Chinese) ‐ Caucasian & Chinese volunteers must match Japanese volunteers for sex, age, height, weight, Body Mass Index (BMI) within specified ranges.
Epistemonikos ID: 2719110404216f53b0bcb782b312fd2785428440
First added on: Aug 25, 2024