Effects of Rifampin on the Pharmacokinetics of Ataluren
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|ClinicalTrials.gov Identifier: NCT02409004|
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Ataluren Drug: Rifampin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Assessing the Effects of Rifampin on the Pharmacokinetics of Ataluren in Healthy Subjects|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Ataluren 1375 mg powder for oral suspension administered once daily on Days 1 and 11 Rifampin 300 mg capsules administered twice daily on Day 3 to Day 12
Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg)
Other Name: Ataluren(PTC124)
Capsule 2x3oo mg Oral
Other Name: Rifadin®
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 12 days ]The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
- Maximum plasma concentration (Cmax) [ Time Frame: 12 days ]The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
- Safety as measured by adverse events, laboratory abnormalities, vital signs, and electrocardiogram parameters [ Time Frame: 12 days ]
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): NCT02409004
|Quebec, Canada, G1P 0A2|
|Study Director:||Oscar Laskin, MD||PTC Therapeutics|