Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03649412
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2018-08-24
Brief Title:
A Study to Investigate the Pharmacokinetics PK of Modified Release MR Prototype Coated Tablet Formulations of GSK2982772
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Two Part Non-randomised Open Label Study Designed to Assess the Pharmacokinetic Profile of Modified Release Prototype Coated Tablet Formulations of GSK2982772 Relative to an Immediate Release Reference Tablet Formulation at a Fixed Strength Part A and the Pharmacokinetic Profile of Alternative Tablet Strengths of the Selected Modified Release Prototype Coated Tablet Formulation Part B Optional in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2020-04
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:
Previous clinical studies of immediate release IR formulations of GSK2982772 resulted in a high peak to trough ratio of GSK2982772 Additionally the short half-life for GSK2982772 approximately 2 to 3 hours necessitates twice a daily BID or thrice daily TID dosing of an IR formulation As a result MR formulations using a polymer matrix approach with minitablets in capsule and MR tablet formulations were investigated The emerging PK data of the MR formulations investigated to date have demonstrated that a once daily QD PK profile can be achieved in the fasted state but the polymer matrix formulation is susceptible to food effects when administered with a high fat breakfast The purpose of this study is to evaluate MR prototype coated tablet formulations This study will evaluate the PK of MR prototype coated tablet formulations of GSK2982772 The study is divided into two parts Part A and Part B The MR tablet coating used in Part A and the initial periods of Part B will have an aperture drilled into the enteric coating of either side of the tablet This allows some drug release to commence in the stomach whilst providing controlled release throughout the gastrointestinal GI tract In Part B only a new investigational medicinal product IMP will be manufactured to allow comparison of the tablet coating either with apertures ie drilled or without apertures ie full coatnon drilled Part A will be a 6-period 6-way fixed sequence design up to 4 MR tablet prototype coated formulations will be evaluated in fasted state at 240 milligrams mg Periods 1 2 and 3 will evaluate MR1 IR tablet and MR2 respectively Periods 4 5 and 6 will be flexible and the dosing regimen will be dependent on the outcome of Periods 1 to 3 In addition the impact of food high fat meal standard breakfast or administration 30 or 60 minutes before a standard breakfast on selected MR prototype coated tablet formulations may also be evaluated in Period 4 5 or 6 of Part A Each inpatient period for MR regimens Periods 1 3 4 to 6 will consist of 4 days and 3 nights and the inpatient period for the IR tablet Period 2 will consist of 3 days and 2 nights There will be a minimum washout of 7 days between doses and a follow-up visit will occur at 7 to 9 days after the last study treatment The Part B of the study will be a 7-period fixed sequence which will evaluate the selected MR prototype coated tablet formulations at different tablet strengths or as multiple unit doses and with or without apertures in the tablet coatings There will be an interim review after each period 1 to 5 of Part B to select the dose level formulation and prandial status for each subsequent period An interim data review after Part B Period 6 will determine if optional Period 7 is required and the dose level dosing time morning or evening formulation and prandial status for that period Each inpatient period will consist of a 4-day and 3-night with a minimum of 7 days washout between doses A follow-up visit will occur at 7 to 9 days after the last study treatment Approximately 33 subjects will be enrolled in the study The total duration for Part A will be approximately 10-12 weeks and 10-14 weeks for Part B including screening period of approximately 4 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002370-48 | EUDRACT_NUMBER | None | None |