Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-29 @ 9:57 AM
Study NCT ID:
NCT03138759
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2017-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probenecid on Pexidartinib Pharmacokinetics
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-05
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 primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.
Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.
Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.
Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.
Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: