NCT06736340

Pharmacokinetics and Safety of Rupatadine in Participants With Hepatic Impairment Compared to Control Participants.

A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Noucor Health S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the PK and safety of rupatadine (10 mg) and its active metabolites in participants with mild, moderate, or severe hepatic impairment compared to matched control participants with normal hepatic function. The study duration will be up to 38 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 hepatic impairment with matched control participants with normal hepatic function (matched in terms of age, gender, 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 10). Additionally, from Day 2 to EOS participants will go back to the clinic every day for blood drawing. 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 postdose. Participants will undergo sequential PK sampling over the following 192 hours along with other safety assessments as described in schedule of activities (SoA). The participant groups will be consecutively enrolled into the study. Enrollment of participants with mild, moderate, and severe hepatic impairment will be staggered, so that dosing of participants with mild hepatic 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-hour postdose of at least 6 participants with hepatic impairment from the previous group and after the assessment of safety and tolerability results are judged to be satisfactory by Safety Committee. An EOS assessment for each participant will occur at Day 10 after the administration of rupatadine. The total study duration for each participant, including Screening, Baseline, Study Period, and EOS assessments, is approximately 38 days.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Rupatadine	10mg tablets

Timeline

• Start date: 2022-11-17
• Primary completion: 2025-04-09
• Completion: 2025-04-09
• First posted: 2024-12-16
• Last updated: 2025-05-28

Locations

7 sites across 2 countries: Portugal, Spain

Regulatory

• FDA-regulated drug study