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
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|ClinicalTrials.gov Identifier: NCT00508768|
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Oral SCIO-469 capsule||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Completion Date :||December 2002|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508768
|Study Director:||Scios, Inc. Clinical Trial||Scios, Inc.|