Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619054
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Single-dose Study for the Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of KP-001
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 open-label non-randomized parallel-group single-dose study to assess the effect of hepatic impairment assessed by the criteria of the Child-Pugh scale on the pharmacokinetics PK and safety of KP-001 in adult male and non-childbearing potential female participants aged 20 years old
The purpose of this study is to evaluate the effect of hepatic impairment on the PK and safety of KP-001 The study will also assess the effect of hepatic impairment on other PK parameters after single dose administration of KP-001
The study will comprise 3 parts and the study period for each part will consist of the following
Screening period Up to 28 days before the administration of study intervention
Treatment Period Participants will be residential at the Clinical Unit from the day before the administration of the single dose of KP-001 Day -1 until Day 3 Discharge
Follow-up Visit 7 days after discharge from the Clinical Unit ie Day 10 Participants will be enrolled into 4 cohorts according to the hepatic function status as summarized below The study includes a control group of healthy participants with normal hepatic function
The purpose of this study is to evaluate the effect of hepatic impairment on the PK and safety of KP-001 The study will also assess the effect of hepatic impairment on other PK parameters after single dose administration of KP-001
The study will comprise 3 parts and the study period for each part will consist of the following
Screening period Up to 28 days before the administration of study intervention
Treatment Period Participants will be residential at the Clinical Unit from the day before the administration of the single dose of KP-001 Day -1 until Day 3 Discharge
Follow-up Visit 7 days after discharge from the Clinical Unit ie Day 10 Participants will be enrolled into 4 cohorts according to the hepatic function status as summarized below The study includes a control group of healthy participants with normal hepatic function
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