Inflammatory Bowel Diseases (IBD) such as ulcerative colitis (UC) or Crohn?s disease (CD) Digestive System
Conditions
Interventions
CCX507-B (30, 60 and 90 mg CCX507-B single dose and multiple doses for 7 days) or placebo. Period 1 involves subjects being randomized to CCX507-B or placebo and being dosed a single time. Period 2 in
Sponsors
ChemoCentryx, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 18-65 inclusive 2. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol 3. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen 4. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding 2. History of use of tobacco and/or nicotine-containing products within the 3 months prior to study entry 3. History of drug abuse within 1 year prior to study entry 4. History of alcohol abuse within 5 years prior to study entry 5. History of any form of cancer 6. Consumed alcoholic beverages, or any food or drink containing grapefruit or Seville oranges within 48 hours prior to Day -1 7. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation 8. Donated or lost more than 50 mL of blood or blood products within 56 days prior to screening, or donated plasma within 7 days of randomization 8. Subject's hemoglobin less than the lower limit of normal at screening 9. Participated in any clinical study of an investigational product within 60 days prior to randomization 10. Subject has any evidence of hepatic disease; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal 11. Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal 12. Subject's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of CCX507-B. Safety is measured by adverse event, serum chemistry, urinalysis, and hematology assessments at Baseline, Days 2 and 4 after the single dose and Baseline, Days 2, 4, 8 and 15 of the multi-dose period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and pharmacodynamic profiles of CCX507-B. Pharmacokinetic profile is assessed on all study days, i.e., Days 1 through 4 of the single dose period and Days 1 through 15 of the multi-dose period. Pharmacodynamic markers are assessed at Baseline and on Days 1 and 2 of the single-dose period, and at Baseline and on Days 1, 2, 4, 5, 7, and 8 of the multi-dose period. | — |
Countries
Netherlands
Outcome results
None listed