Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02706535
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2016-03-07
Brief Title:
A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics PK of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single Center Two Part Randomized Open Label Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
Status:
COMPLETED
Status Verified Date:
2020-11
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 is a Phase I single center two-part randomized open label cross-over study Part 1 of this study will evaluate the PK safety and tolerability of GSK525762 when administered alone and when co-administered following repeat dosing of itraconazole a known strong inhibitor of Cytochrome P450 3A4 CYP3A4 and a Para-glycoprotein Pgp inhibitor Part 1 will consist of 2 Cohorts with preliminary PK and safety data obtained from Cohort 1 informing Cohort 2 Part 2 one Cohort of the study will evaluate the PK safety and tolerability of GSK525762 when administered alone and when co-administered following repeat dosing of rifampicin a known potent inducer of CYP3A4 In vitro inhibition data indicate CYP3A4 may be the major route of clearance for GSK525762 and co-administration of drug therapies which modulate CYP3A4 ieCYP3A4 inhibitors and inducers is likely to alter the exposure of GSK525762 ie increase or decrease exposure respectively The data generated from this current study to justify exclusion criteria on concomitant medications which affect CYP3A4 or Pgp and also inform potential dose modification in case of co-administration with medication affecting CYP3A4 activity All subjects will undergo a screening visit within 28 days of the first dose of study drug followed by one treatment period and a follow-up visit 7-10 days after the last dose of GSK525762 Subjects in Part 1 will participate in the study for up to 45 days and subjects in Part 2 will participate for up to 56 days
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