Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06708520
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Rupatadine in Participants With Renal Impairment Compared to Control Participants
Sponsor:
Noucor Health S.A.
Organization:
Study Overview
Official Title:
A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Renal Impairment Compared to Matched Control Participants With Normal Renal Function
Status:
RECRUITING
Status Verified Date:
2024-11
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 purpose of this study is to assess the PK, tolerability, and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function.
The study duration will be up to 40 days, including Screening, Baseline, Study Period, and EOS visit assessments.
Rupatadine 10 mg tablet will be administered as single dose.
The study duration will be up to 40 days, including Screening, Baseline, Study Period, and EOS visit assessments.
Rupatadine 10 mg tablet will be administered as single dose.
Detailed Description:
This is an open-label, non-randomized, parallel group study comparing the PK after administration of a single 10 mg dose of rupatadine to participants with renal impairment with matched control participants with normal renal function (matched in terms of gender, age, and body weight).
For each participant, the study visits will consist of a Screening Period (Day -28 to Day -2), a Baseline evaluation (Day -1), a single dose treatment period (Day 1) and an End of Study (EOS) Visit (Day 12 for subjects with renal impairment and Day 8 for subjects with normal real function). Additionally, from Day 2 to EOS participants will go back to the clinic for blood drawing according to schedule.
Participants who meet the eligibility criteria at Screening and Baseline will be enrolled into the study.
All Baseline safety evaluation results must be reviewed prior to dosing. Participants will be domiciled at the clinic from Day -1 until 24 hours after dosing on Day 1 (Day 2).
On Day 1, participants will receive a single dose of rupatadine 10 mg after an overnight fast of 10 hours and will continue to fast for 4 hours post-dose.
Participants with renal impairment will undergo sequential PK sampling over the following 264 hours along with other safety assessments. Participants with normal renal function will undergo sequential PK sampling over the following 144 hours along with other safety assessments.
The participant groups will be consecutively enrolled into the study. Enrollment of participants with mild, moderate, and severe renal impairment will be staggered, so that dosing of participants with mild renal impairment will be started first. Dosing of the next group will be started only after evaluation of blood PK, safety and tolerability data until 72 hours post dose of at least six participants with renal impairment from the previous group and after the assessment of safety and tolerability results are judged to be satisfactory by the Safety Committee.
An EOS assessment will occur 7 days after the administration of rupatadine in the participants with normal renal function and 11 days after in renal impaired participants.
The total study duration, including Screening, Baseline, Study Period, and EOS assessments, is up to approximately 40 days.
For each participant, the study visits will consist of a Screening Period (Day -28 to Day -2), a Baseline evaluation (Day -1), a single dose treatment period (Day 1) and an End of Study (EOS) Visit (Day 12 for subjects with renal impairment and Day 8 for subjects with normal real function). Additionally, from Day 2 to EOS participants will go back to the clinic for blood drawing according to schedule.
Participants who meet the eligibility criteria at Screening and Baseline will be enrolled into the study.
All Baseline safety evaluation results must be reviewed prior to dosing. Participants will be domiciled at the clinic from Day -1 until 24 hours after dosing on Day 1 (Day 2).
On Day 1, participants will receive a single dose of rupatadine 10 mg after an overnight fast of 10 hours and will continue to fast for 4 hours post-dose.
Participants with renal impairment will undergo sequential PK sampling over the following 264 hours along with other safety assessments. Participants with normal renal function will undergo sequential PK sampling over the following 144 hours along with other safety assessments.
The participant groups will be consecutively enrolled into the study. Enrollment of participants with mild, moderate, and severe renal impairment will be staggered, so that dosing of participants with mild renal impairment will be started first. Dosing of the next group will be started only after evaluation of blood PK, safety and tolerability data until 72 hours post dose of at least six participants with renal impairment from the previous group and after the assessment of safety and tolerability results are judged to be satisfactory by the Safety Committee.
An EOS assessment will occur 7 days after the administration of rupatadine in the participants with normal renal function and 11 days after in renal impaired participants.
The total study duration, including Screening, Baseline, Study Period, and EOS assessments, is up to approximately 40 days.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: