A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants
- Conditions
- GoutInflammatory and Immune System - Other inflammatory or immune system disordersMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12623001038684
- Lead Sponsor
- Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
* Male and/or childbearing or non-childbearing potential female participants
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG at the time of Screening, as deemed by the Investigator
* Body weight no less than 50 kg and body mass index (BMI) between 18 and 33 kg/m2
* Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 µmol/L) and estimated glomerular filtration fate (eGFR, by Cockcroft Gault formula) greater than or equal to 90 mL/min.
* Inadequate venous access or unsuitable veins for repeated venipuncture.
* Positive serology to HIV and/or hepatitis C virus , and/or hepatitis B surface antigen (HBsAg).
* History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders that are not well controlled as per the Investigator’s judgment.
* History and/or presence of drug addiction or excessive use of alcohol within 12 months.
* Heavy caffeine drinker, > 5 servings (8-ounce/240 mL per serving) of caffeinated beverages (e.g., coffee, tea, cola, etc.) per day.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method