Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01867996
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2013-05-30
Brief Title:
A Study to Evaluate the Pharmacokinetics Safety and Tolerability of Retosiban GSK221149 When Dosed With Efavirenz EFZ
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
To Evaluate the Pharmacokinetics Safety and Tolerability of Retosiban GSK221149 Co-administered With EFAVIRENZ
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This will be a randomized single sequence open label study This study is designed to determine if chronic dosing with efavirenz EFZ will have an effect on the pharmacokinetics PK of intravenously-administered retosiban in healthy volunteers The study consists of screening 28 days treatment 1 dosing session and follow-up 7 to 14 days period and the total duration of study participation for each subject will be approximately 8 weeks During the treatment period subjects will be admitted to the clinical research unit the day before dosing Day 1 and will remain until completion of the last assessment on Day 20 All subjects will receive on Day 1 a 6 milligrams mg bolus of retosiban for 5 minutes min followed by a 6 mghour hr infusion for 12 hrs On Day 2 a washout day will occur On Days 3-17 subjects will receive EFZ 600 mg once daily in the evening On Day 18 subjects will receive a 6 mg bolus of retosiban for 5 mins followed by a 6 mghr infusion for 12 hrs plus a 600 mg dose of EFZ
Detailed Description:
None
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