Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02136888
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2014-05-09
Brief Title:
Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Single-center Double-blind Randomized Placebo- and Positive-controlled Parallel-group Multiple-dose Up-titration Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma exposures to ponesimod do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern as measured by the QTc interval from beginning of the Q wave until end of the T wave corrected for heart rate interval duration after administration of multiple oral doses of 40 mg and 100 mg to healthy male and female subjects
Detailed Description:
This is a Phase 1 single-center double-blind randomized placebo and positive-controlled double-dummy parallel group multiple-dose up-titration study of the electrocardiographic effects of ponesimod in healthy male and female subjects with a nested cross-over comparison between moxifloxacin and placebo
Subjects will be randomly assigned to Group A ponesimod treatment group or Group B placebo treatment group in a 11 ratio Subjects in Group B will be further randomized in a 11 ratio to one of the following sequences 400 mg moxifloxacin followed by moxifloxacin-matching placebo or moxifloxacin matching placebo followed by 400 mg moxifloxacin
Subjects will be randomly assigned to Group A ponesimod treatment group or Group B placebo treatment group in a 11 ratio Subjects in Group B will be further randomized in a 11 ratio to one of the following sequences 400 mg moxifloxacin followed by moxifloxacin-matching placebo or moxifloxacin matching placebo followed by 400 mg moxifloxacin
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