A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis
The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis|
- Pharmacokinetic parameters will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate).
- Safety variables will be assessed on Day 19, seven days after the end of treatment, and will include adverse events, concomitant medications, and clinical assessments (medical history, physical exam, vital signs, 12-lead ECG, and clinical labs).
|Study Completion Date:||December 2002|
SCIO-469 is being developed for the treatment of active rheumatoid arthritis, a disease that occurs mostly in women; therefore, female patients with active rheumatoid arthritis are selected as the study population. This study is the first detailed pharmacokinetic evaluation (study of a drug in the body to watch how the drug is absorbed, distributed, metabolized and eliminated over a period of time) of SCIO-469 in a new capsule formulation. Methotrexate is frequently prescribed as treatment for patients with rheumatoid arthritis; thus, SCIO-469 could potentially be used along with methotrexate. It is not known how methotrexate affects the pharmacokinetics of SCIO-469; therefore, the study is designed to include patients who are taking stable doses of methotrexate and patients who are not taking methotrexate. This is a Phase II, randomized (study medication assigned by chance), double-blind (neither the patient or the physician knows which study treatment the patient is receiving), parallel-group study designed to assess the pharmacokinetics, safety, and tolerability of SCIO-469 in female patients with active rheumatoid arthritis. Sixteen patients will be enrolled in the study, with eight receiving stable doses of methotrexate and eight not receiving methotrexate. No other disease-modifying anti-rheumatic drugs (DMARDs) are allowed. Pharmacokinetics will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate). Safety assessments for this study include clinical adverse events, concomitant medications, and clinical assessments (medical history, physical examination, vital and orthostatic vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations [serum chemistry, urinalysis, hematology, liver function and other tests, and pregnancy test]). Patients receiving stable doses of methotrexate (taken once a week, either orally or by injection) and those not receiving methotrexate will be randomized into one of two oral capsule SCIO-469 dosing regimens: 30 mg three times a day and 90 mg once a day. Patients will take study drug for 11 of 12 days, with no study drug taken on Day 2. On Day 19, seven days after the end of treatment, patients will undergo a follow-up assessment of safety variables.