CCX168 tolerability Signs and Symptoms CCX168 tolerability
Conditions
Interventions
Participants are randomly allocated to one of five cohorts, which in turn are randomised to receive a different dosage of CCX168 or a placebo. Each cohort undergoes two study periods: a single dose an
Sponsors
ChemoCentryx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 19-45 years inclusive, who are in generally good health, whose body mass index is 19 to 29 kg/m^2 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. Judged to be healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study. 5. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening and/or on Study Day -1 2. Expected requirement for use of any medication (with the exception of continuing use by female subjects of hormonal contraceptives in accordance with a regimen that has been stable for at least the three months prior to Screening) during the study period 3. History within the three months prior to study entry of use of tobacco and/or nicotine-containing products 4. History within one year prior to study entry of illicit drug use 5. History of alcohol abuse at any time in the past 6. History of any form of cancer 7. Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit juice within 24 hours of screening 8. 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 9. Donated or lost more than 350 mL of blood or blood products within 56 days prior to screening, or donated plasma within 7 days of randomization 10. Subject's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L) 11. Participated in any clinical study of an investigational product within 30 days prior to randomization 12. Subject has any evidence of hepatic disease; AST, ALT, GGT, alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal 13. Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal 14. 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 (Breathalyzer test allowed for alcohol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of CCX168 as measured by the incidence of adverse events and changes in safety laboratory measurements on Days 2, 3, 4, and 8 in Period 1, and Days 2 through 10, 15 and 29 in Period 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic profile of single and multiple oral doses of CCX168 using high-performance liquid chromatography-tandem mass spectrometry on Days 1 through 4 and Day 8 in Period 1, and Days 2 through 10 and Day 15 in Period 2. 2. The relationship between CCX168 plasma concentrations and complement 5a receptor (C5aR)-dependent CD11b upregulation in circulating neutrophils, and the relationship between CCX168 plasma concentrations and C5aR-dependent cell migration in a whole blood migration assay on Day 1 of Period 1 and Day 7 of Period 2 | — |
Countries
Switzerland
Outcome results
None listed