Ignite Creation Date:
2024-05-05 @ 10:27 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01114607
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2010-04-29
Brief Title:
A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Dose Randomized Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A CCX282 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-07
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 is an open-label single dose randomized five-period crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb PROTECT-1 Study and ChemoCentryx Thorough QTQTc Study
Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study
Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study
Detailed Description:
This will be a randomized open-label single-dose five-period crossover study in healthy volunteers to compare the relative bioavailability of 5 oral GSK1605786 formulations Recruitmentscreening will occur within approximately 30 days of the first scheduled dose of study medication Each subject will participate in five dosing sessions - each dose will be separated by at least seven days The total duration of a subjects participation in the study from Screening to Follow-up is approximately 10 weeks
All subjects will receive single 500mg doses of the following five GSK1605786 formulations A ChemoCentryx formulation of GSK1605786 2 x 250mg capsules Formulation A B GSK formulation of GSK1605786 2 x 250mg capsules Formulation B C GSK direct-fill formulation of GSK1605786 2 x 250mg capsules Formulation C D GSK modified formulation of GSK1605786 2 x 250mg capsules Formulation D E GSK tablet formulation of GSK1605786 500mg tablet Formulation E
Formulations A and B will administered in periods 1 and 2 in a random order and formulations C D and E will be administered in periods 3 4 and 5 in a random order
Subjects will check into the clinical research unit CRU 1 day prior to dosing Day -1 The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast ie fed state For each treatment period subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3 Subjects may be released from the clinic on Day 3 after all required study procedures are completed and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples
Upon completion of the last dosing period or early withdrawal subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study
The study will be conducted at one center
All subjects will receive single 500mg doses of the following five GSK1605786 formulations A ChemoCentryx formulation of GSK1605786 2 x 250mg capsules Formulation A B GSK formulation of GSK1605786 2 x 250mg capsules Formulation B C GSK direct-fill formulation of GSK1605786 2 x 250mg capsules Formulation C D GSK modified formulation of GSK1605786 2 x 250mg capsules Formulation D E GSK tablet formulation of GSK1605786 500mg tablet Formulation E
Formulations A and B will administered in periods 1 and 2 in a random order and formulations C D and E will be administered in periods 3 4 and 5 in a random order
Subjects will check into the clinical research unit CRU 1 day prior to dosing Day -1 The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast ie fed state For each treatment period subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3 Subjects may be released from the clinic on Day 3 after all required study procedures are completed and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples
Upon completion of the last dosing period or early withdrawal subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study
The study will be conducted at one center
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