None listed
Conditions
Brief summary
A trial in healthy adults to evaluate how AR882 may interact with common drugs such as fluconazole, carbamazepine, celecoxib, and sulfasalazine.
Interventions
This study will be conducted at two study centers. There will be 5 treatment groups with up to 14 participants per treatment group. Treatment Groups 1 to 5 may be conducted in parallel.
Dosing: Participants will orally ingest Investigational Product (IP) after an overnight fast of at least 10 hours and will remain fasted until at least 4 hours post-dose. Subjects may ingest water ad libitum during the period of fasting before and after IP administration except 1 hour before dosing and up to 1 h
This study will be conducted at two study centers. There will be 5 treatment groups with up to 14 participants per treatment group. Treatment Groups 1 to 5 may be conducted in parallel. Dosing: Participants will orally ingest Investigational Product (IP) after an overnight fast of at least 10 hours and will remain fasted until at least 4 hours post-dose. Subjects may ingest water ad libitum during the period of fasting before and after IP administration except 1 hour before dosing and up to 1 hour post-dosing. All participants will be observed at the time of dosing by site staff to confirm ingestion of the study drug. Participants will be allocated to each group in the following manner, 1st 10 eligible participants will dose in Group 3, next 10 eligible participants will dose in Group 1, the next 10 eligible participants will dose in Group 4, the next 10 eligible participants will dose in Group 2, and the next 14 eligible participants will dose in Group 5. Segment A (CYP2C9 Evaluation): Group 1: AR882 (50 mg) oral capsule once daily on Days 1 and 8; AND Fluconazole (400 mg) (oral capsule) on Day 7, then 200 mg on Days 8 and 9 Group 2: AR882 (75 mg) oral capsule once daily on Days 1 and 20; AND Carbamazepine 200 mg (solid oral tablet) per day on Days 7 to 9, then 400 mg per day on Days 10 to 12, then 600 mg per day on Days 13 to 21 Group 3: AR882 (75 mg) oral capsule once daily on Days 4 to 6; AND Celecoxib 200 mg (oral capsule) on Days 1 and 5 Segment B (BCRP Evaluation): Group 4: AR882 (75 mg) once daily on Days 4 to 6; AND Sulfasalazine 500 mg (solid oral tablet) on Days 1 and 5 Group 5: AR882 (75 mg) oral capsule once daily on Days 1 and 22; AND Carbamazepine 200 mg (solid oral tablet) per day on Days 6 to 8, then 400 mg per day on Days 9 to 15, then 600 mg per day on Days 16 to 23
Sponsors
Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Outcome results
None listed