A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects.
Completed
- Conditions
- 10017969Crohn's disease.Inflammatory bowel diseases
- Registration Number
- NL-OMON40895
- Lead Sponsor
- ChemoCentryx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Healthy male or female
18 - 65 years inclusive
BMI 18.0 -30.0 kilograms/meter2
non smoker
Exclusion Criteria
Suffering form hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in another drug study within 60 days prior to randomization.
Any donation of blood (products) or significant blood loss within 56 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate the safety and tolerability<br /><br>of single and multiple oral doses of CCX507-B, over a range of 3 dose levels,<br /><br>in healthy male and female subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* The effect of food on the PK profile of CCX507-B; and<br /><br>* The relationship between CCX507 plasma concentrations and blockade of the C-C<br /><br>chemokine receptor 9 (CCR9) on circulating leukocytes.</p><br>