Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01827644
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2013-04-05
Brief Title:
Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Center Randomized Open-Label Sequential Single Dose 4-Period Crossover Study to Evaluate the Bioavailability and Food Effect of a Gelatin Formulation and Two Prototype Formulations of Afuresertib an AKT Inhibitor in Normal Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-11
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 open-label sequential single dose 4-period crossover study This study is being conducted to measure the relative bioavailability of the original gelatin capsule GC formulation and two new formulations hydroxypropyl-methylcellulose HPMC capsule and enteric coated tablet ECT of afuresertib AFU in the fed and fasted state The study will be composed of Screening Treatment and Follow-up Periods Screening assessments to determine subject eligibility will be performed within 3 weeks prior to the first dose of study drug in the Treatment Period Eligible subjects will be randomized to receive 4 of the 6 possible study treatments A AFU GC administered in a fasted state B AFU GC administered in a fed state C AFU HPMC capsule administered in a fasted state D AFU HPMC capsule administered in a fed state E AFU ECT administered in a fasted state F AFU ECT administered in a fed state in 4 treatment periods one per treatment period Subjects will receive a single dose of one of the six study treatments A B C D E F on Day 1 of each Dosing Period according to one of the 6 treatment sequences CEDA EFAB ABFC BDCE FCBD DAEF There will be a minimum of 10 Day washout period between the doses administered in each Treatment Period A Follow-up visit will be conducted within 10-14 days after the last dose A subjects total time involved in the study will be approximately 9 weeks At least 36 subjects will be enrolled in the study to ensure that at least 6 subjects will be randomized to receive each treatment sequence
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