Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00996268
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2009-10-15
Brief Title:
An Open-label Single Dose Randomized Parallel Group Study Followed by Single-blind Repeat Dosing to Compare the Relative Bioavailability of GSK2212836
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-label Single Dose Randomized Parallel Group Study Followed by Single-blind Repeat Dosing to Compare the Relative Bioavailability of GSK2212836
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1 Once the pharmacokinetic parameters of the formulations have been analyzed doses of GSK2212836 will be selected for further study in Part B Subjects from Part A will participate in Part B
Part B is a single blind randomized placebo controlled study that will consist of a 2-week repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836 Subjects will check in to the clinical unit on Day -3 will participate in a test meal on Day -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1 Subjects will be released from the clinic on Day 2 and return for daily dosing on Days 3 through 12 On Day 6 they will also have a brief outpatient visit Subjects will check into the clinic again on the evening of Day 12 and on Day 13 they will again have 24-hr pharmacokinetic profiles collected Subjects will be released from the clinical research unit on Day 14 following a test meal triglyceride sampling and check-out assessments and will be released from the study 5-10 days later after completing a follow up visit
Part B is a single blind randomized placebo controlled study that will consist of a 2-week repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836 Subjects will check in to the clinical unit on Day -3 will participate in a test meal on Day -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1 Subjects will be released from the clinic on Day 2 and return for daily dosing on Days 3 through 12 On Day 6 they will also have a brief outpatient visit Subjects will check into the clinic again on the evening of Day 12 and on Day 13 they will again have 24-hr pharmacokinetic profiles collected Subjects will be released from the clinical research unit on Day 14 following a test meal triglyceride sampling and check-out assessments and will be released from the study 5-10 days later after completing a follow up visit
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