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

Influence of Race/Ethnic Origin on the Pharmacokinetics of SCH 527123 (in Healthy Volunteers).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000218291

Enrollment

Registered

2009-04-30

Start date

2009-07-07

Completion date

2010-04-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Demographic variables such as age, sex, race and body weight as well as genetic, environmental and cultural factors (eg, diet) may influence the safety & therapeutic response to drugs. Therefore, this study aims to investigate these differences in Japanese, Chinese and Caucasian subjects.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Exclusion criteria

History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Neutrophil count of <2 x 10 9.

Outcome results