A Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics SCH 900931 in Healthy Adult Japanese Subjects.
- Conditions
- Healthy volunteersOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12611000568910
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation, a Subsidiary of Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy Japanese volunteers
Exclusion Criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: To evaluate the safety and tolerability of rising single oral doses of SCH 900931 administered to healthy adult Japanese subjects. (Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)[Assessed throughout the study at each study visit up to Day 6 of period 3.];Part 2: To evaluate the safety and tolerability of rising multiple oral doses of SCH 900931 administered to healthy adult Japanese subjects. (Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)[Assessed throughout the study at each study visit up to Day 21.]
- Secondary Outcome Measures
Name Time Method Part 1: To compare the single dose pharmacokinetic of SCH 900931 in healthy adult Japanese subjects to those obtained from healthy adult non-Japanese subjects (historical data from previous studies). (Assessed via pharmacokinetic blood sampling)[Assessed throughout the study at each study visit up to Day 6 of period 3 (part 1)];Part 2: To obtain preliminary plasma pharmacokinetic data of SCH 900931 following multiple oral dose administration in healthy adult Japanese subjects.<br><br>(Assessed via pharmacokinetic blood sampling)[Assessed throughout the study at each study visit up to or Day 21 (Part 2).]