Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592482
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics Safety and Tolerability of AZD0780
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Single-Dose Non-Randomised Open-Label Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics Safety and Tolerability of AZD0780
Status:
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 I multi-centre single-dose non-randomised open-label parallel-group study to examine the PK safety and tolerability of AZD0780 in male and female participants females of non-childbearing potential with severe renal impairment not on dialysis end-stage renal disease ESRD on intermittent haemodialysis HD or moderate renal impairment optional compared with male and female participants females of non-childbearing potential with normal renal function Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention Eligible participants will be admitted to the study site on Day -1 On Day 1 an A single oral dose of AZD0780 will be administered and participants will be confined to the study site until after assessments are completed on Day 11
Detailed Description:
This is a Phase I multi-centre single-dose non-randomised open-label parallel-group study to examine the PK safety and tolerability of AZD0780 in male and female participants females of non-childbearing potential with severe renal impairment not on dialysis end-stage renal disease ESRD on intermittent haemodialysis HD or moderate renal impairment optional compared with male and female participants females of non-childbearing potential with normal renal function
Participants will be assigned to the following groups based on body surface area-adjusted estimated glomerular filtration rate eGFR determined by a local laboratory at screening by the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation 2021 using serum creatinine
Group 1 Participants with severe renal impairment eGFR 30 mLmin not on dialysis
Group 2 Participants with ESRD eGFR 15 mLmin on a stable intermittent HD schedule for at least 3 months prior to planned dosing
Group 3 Participants with normal renal function demographically matched by sexage and body mass index BMI to the impaired participants eGFR of 90 mLmin
Group 4 optional Participants with moderate renal impairment eGFR 30 to 60 mLmin
Initially participants with severe renal impairment Group 1 and ESRD Group 2 will be enrolled along with matching participants with normal renalfunction An analysis of PK datamay be conducted to determine study progression The decision to trigger the PK analysis andor proceed with an evaluation of participants with moderate renal impairment Group 4 will be made by the sponsor
Each matched participant with normal renal function Group 3 enrolled in the study will be demographically matched by sex age 10 years and BMI 20 kgm2 data obtained at screening to an enrolled renal impairment participant Participants with normal renal function cannot be matched to more than one renally impaired participant within an impairment group however participants with normal renal function may be matched to 1 participant from more than 1 renal impairment group
Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention Eligible participants will be admitted to the study site on Day -1 On Day 1 a A single oral dose of AZD0780 will be administered and participants will be confined to the study site until after assessments are completed on Day 11
For participants with ESRD Group 2 the first post dose HD session should be scheduled to start 26 hours after administration of AZD0780 Subsequent HD sessions should be scheduled as clinically appropriate
Serial PK venous blood samples will be collected up to 240 hours postdose and urine samples will be collected up to 96 hours postdose for the measurement of AZD0780 Urine collection is not required for participants who are anuric ie participants with ESRD on HD Group 2 For participants with ESRD Group 2 blood samples for PK analysis will also be collected prior to during and at the end of HD The entire dialysate will be collected in separate hourly collections on Day 2 for participants with ESRD Group 2 for the measurement of AZD0780 The volume of each hourly collection of dialysate from which a sample is taken will be recorded Physical examinations 12-lead electrocardiograms vital sign measurements and clinical laboratory tests will be performed to assess safety and tolerability
Participants will be assigned to the following groups based on body surface area-adjusted estimated glomerular filtration rate eGFR determined by a local laboratory at screening by the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation 2021 using serum creatinine
Group 1 Participants with severe renal impairment eGFR 30 mLmin not on dialysis
Group 2 Participants with ESRD eGFR 15 mLmin on a stable intermittent HD schedule for at least 3 months prior to planned dosing
Group 3 Participants with normal renal function demographically matched by sexage and body mass index BMI to the impaired participants eGFR of 90 mLmin
Group 4 optional Participants with moderate renal impairment eGFR 30 to 60 mLmin
Initially participants with severe renal impairment Group 1 and ESRD Group 2 will be enrolled along with matching participants with normal renalfunction An analysis of PK datamay be conducted to determine study progression The decision to trigger the PK analysis andor proceed with an evaluation of participants with moderate renal impairment Group 4 will be made by the sponsor
Each matched participant with normal renal function Group 3 enrolled in the study will be demographically matched by sex age 10 years and BMI 20 kgm2 data obtained at screening to an enrolled renal impairment participant Participants with normal renal function cannot be matched to more than one renally impaired participant within an impairment group however participants with normal renal function may be matched to 1 participant from more than 1 renal impairment group
Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention Eligible participants will be admitted to the study site on Day -1 On Day 1 a A single oral dose of AZD0780 will be administered and participants will be confined to the study site until after assessments are completed on Day 11
For participants with ESRD Group 2 the first post dose HD session should be scheduled to start 26 hours after administration of AZD0780 Subsequent HD sessions should be scheduled as clinically appropriate
Serial PK venous blood samples will be collected up to 240 hours postdose and urine samples will be collected up to 96 hours postdose for the measurement of AZD0780 Urine collection is not required for participants who are anuric ie participants with ESRD on HD Group 2 For participants with ESRD Group 2 blood samples for PK analysis will also be collected prior to during and at the end of HD The entire dialysate will be collected in separate hourly collections on Day 2 for participants with ESRD Group 2 for the measurement of AZD0780 The volume of each hourly collection of dialysate from which a sample is taken will be recorded Physical examinations 12-lead electrocardiograms vital sign measurements and clinical laboratory tests will be performed to assess safety and tolerability
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