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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT02409004
Brief Summary:
This will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
Detailed Description:
A total of 15 healthy, adult, male non-smokers, were included in this study. Subjects were administered ataluren on Day 1 followed by rifampin from Days 3 to12, and again ataluren on Day 11. On Day 11, ataluren was administered before rifampin administration.
Prior to entering the trial, subjects had a screening visit to establish eligibility within 28 days before study drug administration. Subjects were confined from at least10 hours before the first ataluren dosing on Day 1 until approximately 50 hours postdose(Day 3). Thereafter, subjects came back every morning from Days 4 to 10 for rifampin dosing. Then, subjects reported to the clinical site at least 10 hours before ataluren dosing on Day 11 (evening of Day 10) and remained in the clinical site until after 50 hours post-Day 11 ataluren dose (Day 13).
Study:
NCT02409004
Study Brief:
Protocol Section:
NCT02409004