Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587622
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2020-09-29
Brief Title:
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase 1 Open-label Single-dose Parallel-group Study to Evaluate the Systemic Pharmacokinetics of Icenticaftor in Participants With Mild Moderate or Severe Hepatic Impairment Compared to Matched Healthy Control Participants
Status:
COMPLETED
Status Verified Date:
2024-06
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 purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics safety and tolerability of icenticaftor in participants with varying degrees of hepatic impairment
Detailed Description:
This is a Phase 1 multi-center study with parallel groups The study employs a single-dose open-label design in subjects with mild moderate or severe hepatic impairment along with matched healthy control subjects with normal hepatic function Subjects with normal hepatic function will be matched with subjects with hepatic impairment for gender age 10 years body weight 15 and smoking status smoker or non-smoker
Up to a total of 48 participants will be enrolled in this study approximately 8 in each mild Child-Pugh A moderate Child-Pugh B severe hepatic impairment Child-Pugh C groups and up to 24 healthy control subjects Each participant will receive a single oral dose of 300 mg of icenticaftor QBW251 on Day 1 under fasting conditions
The study is comprised of an up to 28-day screening period Days -28 to -1 a baseline evaluation Day -1 prior to treatment on Day 1 and a follow-up period of 7 days for pharmacokinetics PK sample collection pre-dose 05 1 2 3 4 6 8 10 12 24 36 48 72 96 120 144 and 168 hours post-dose A safety follow-up contact will be done 30 days after administration of the study drug
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic PK safety and tolerability of icenticaftor in participants with varying degrees of hepatic impairment
Up to a total of 48 participants will be enrolled in this study approximately 8 in each mild Child-Pugh A moderate Child-Pugh B severe hepatic impairment Child-Pugh C groups and up to 24 healthy control subjects Each participant will receive a single oral dose of 300 mg of icenticaftor QBW251 on Day 1 under fasting conditions
The study is comprised of an up to 28-day screening period Days -28 to -1 a baseline evaluation Day -1 prior to treatment on Day 1 and a follow-up period of 7 days for pharmacokinetics PK sample collection pre-dose 05 1 2 3 4 6 8 10 12 24 36 48 72 96 120 144 and 168 hours post-dose A safety follow-up contact will be done 30 days after administration of the study drug
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic PK safety and tolerability of icenticaftor in participants with varying degrees of hepatic impairment
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?:
None