Viewing Study NCT05848648



Ignite Creation Date: 2024-05-06 @ 6:58 PM
Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05848648
Status: RECRUITING
Last Update Posted: 2024-04-09
First Post: 2023-04-14

Brief Title: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Sponsor: Qianfoshan Hospital
Organization: Qianfoshan Hospital

Study Overview

Official Title: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Status: RECRUITING
Status Verified Date: 2024-04
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: This is a non-intervention prospective one-arm observational real-world clinical trial The researchers plan to recruit at least 50 qualified patients The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions
Detailed Description: In recent years the advent of polyADP-ribose polymerasePARP inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent selective oral PARP 12 inhibitor In preclinical models pamiparib demonstrated PARP-DNA complex trapping brain penetration antitumor activity and inhibition of PARylation

Therefore at least 50 patients using pamiparib will be included Before and after treatment the laboratory examination data blood concentration combined medication and adverse events of the patients will be collected The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
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