Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT01239459
Brief Summary:
Primary Objective:
\- To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects
Secondary Objective:
\- To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects with severe renal impairment compared to subjects with normal renal function.
Detailed Description:
The total study duration per subject is 11-15 weeks broken down as follows:
* Screening: up to 3 weeks
* Hospitalization: 3 days (admission 1 day prior to study drug intake)
* Follow-up: 10 -12 weeks
Study:
NCT01239459
Study Brief:
Protocol Section:
NCT01239459