Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508768
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2007-07-27
Brief Title:
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
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None