Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488215
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2007-06-19
Brief Title:
A Trial in Healthy Volunteers to Evaluate the Tolerability and Cardiac Safety of Prucalopride
Sponsor:
Movetis
Organization:
Movetis
Study Overview
Official Title:
A Double-Blind Placebo-Controlled 2-Way Cross-Over Trial in Healthy Volunteers to Evaluate the Pharmacokinetics Tolerability and Cardiac Safety of Oral Prucalopride at Steady State After up-Titration to a Maximum of 20 mg
Status:
COMPLETED
Status Verified Date:
2007-06
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:
An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg
Detailed Description:
This is a single-centre double-blind placebo-controlled cross-over trial in 32 healthy volunteers with two sessions I and II Each session consists of a run-in day for baseline assessments 13 treatment days and 5 additional days for assessments Subjects will be randomized to start with either the prucalopride or placebo session
Between the 2 sessions there will be a washout period of 14 to 21 days to avoid any carry-over effect
Between the 2 sessions there will be a washout period of 14 to 21 days to avoid any carry-over effect
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