Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-29 @ 4:09 PM
Study NCT ID:
NCT04981704
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants
Sponsor:
Spectrum Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Three-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2021-09
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:
The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants.
Detailed Description:
This is a three-part study. Participants will be enrolled in Part 1 (Effects of Itraconazole), Part 2 (Effects of Phenytoin), or Part 3 (Effects of Paroxetine) on the Pharmacokinetics of Poziotinib. Each part will be an open-label, fixed-sequence, 2-period study and may be conducted concurrently. For each study part, participants will be housed on Day -1 of Treatment Period 1 in the Clinical Research Unit (CRU) and will remain confined in the CRU until after the last scheduled blood draw and/or study procedures in Treatment Period 2. In each part, there will be a washout period of at least 8 days between poziotinib doses.
A total of 75 (25 in each part) healthy, adult male and female participants will be enrolled targeting a female/male ratio greater than or equal to (≥) 1:3 in each study part.
In part 1, CYP2D6 extensive metabolizers will be primarily enrolled with a goal of enrolling at least 2 CYP2D6 poor metabolizers. In Parts 2 and 3, only CYP2D6 extensive metabolizers will be enrolled. In Part 2, CYP2C9 and CYP2C19 poor metabolizers will be excluded.
A total of 75 (25 in each part) healthy, adult male and female participants will be enrolled targeting a female/male ratio greater than or equal to (≥) 1:3 in each study part.
In part 1, CYP2D6 extensive metabolizers will be primarily enrolled with a goal of enrolling at least 2 CYP2D6 poor metabolizers. In Parts 2 and 3, only CYP2D6 extensive metabolizers will be enrolled. In Part 2, CYP2C9 and CYP2C19 poor metabolizers will be excluded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: