bacterial infections
Conditions
Interventions
Part A:
The volunteer will receive CG-549 three times as oral tablets with 240
milliliters of water. The volunteer will receive CG-549 after eating a high-fat
standardized breakfast. This breakfast
Sponsors
CrystalGenomics, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female; females may be of childbearing potential or of nonchildbearing potential (i.e., either surgically sterilized, physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months and a serum follicle stimulating hormone (FSH) >33.4 IU/L]). 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening. 4. Weight: >=50 kg at screening. 5. Status: healthy subjects.
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening. 4. Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening. 5. History of diseases or abnormalities of the liver or biliary system, other than uncomplicated hepatitis A.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: - Plasma and urine CG-549 concentrations will be measured. - The following plasma PK parameters will be estimated using noncompartmental analysis from the plasma concentration-time data: Cmax, tmax, kel, t*, AUC0-t, AUC0-inf, CL/F, and Vd/F. - The following urine PK parameters will be estimated using noncompartmental analysis from the urine concentration-time data: Aeurine and CLR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety : Adverse events, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. | — |
Countries
Netherlands
Outcome results
None listed