Actively Recruiting
Pharmacokinetics and Safety of Rupatadine 10 mg in Participants With Renal Impairment Compared to Matched Controls With Normal Renal Function
Led by Noucor Health S.A. · Updated on 2025-05-28
48
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing how the drug rupatadine 10 mg and its active metabolites behave in the bodies of participants with kidney problems compared to those with normal kidney function. The study focuses on the drugs pharmacokinetics how it is absorbed, distributed, metabolized, and excreted, its tolerability, and safety. This open-label, non-randomized study includes adult participants with varying degrees of renal impairment and matched controls without kidney issues. Participants will receive a single 10 mg dose of rupatadine after fasting overnight. The study involves a Screening period up to 28 days before dosing, a Baseline evaluation one day before dosing, a dosing day, and an End of Study visit occurring 8 days after dosing for those with normal kidney function and 12 days for those with renal impairment. Blood samples for drug level measurements and safety assessments will be collected frequently during the study, with participants staying at the clinic from one day before dosing until 24 hours after dosing. Participants will undergo various assessments including blood draws to monitor drug levels over time and safety evaluations such as vital signs, ECGs, and laboratory tests. The study will measure detailed pharmacokinetic parameters like peak plasma concentration, half-life, and clearance of rupatadine and its metabolites. The total participation time is up to approximately 40 days, covering all study visits and assessments.
CONDITIONS
Brief Title
Pharmacokinetics and Safety of Rupatadine in Participants With Renal Impairment Compared to Control Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Caucasian subjects aged 18 to 75 years
- Body mass index between 18 and 35 kg/m2 at Screening
- Able to understand study procedures and provide written informed consent
- Able to communicate well and comply with study requirements
- Willing to follow study restrictions including lifestyle considerations
- Women of childbearing potential must have negative pregnancy tests and use effective contraception
- Women not of childbearing potential must meet specific reproductive criteria
- Male participants must be infertile, vasectomized, or agree to use contraception
- Negative tests for HIV, Hepatitis B, and Hepatitis C
- Agree to avoid grapefruit and related products from 7 days before dosing until study end
- Able to tolerate venipuncture
- Participants with renal impairment must be hemodynamically stable with chronic, stable renal impairment and meet specific estimated GFR ranges
- Stable medications for at least 21 days prior to dosing
- Blood pressure and pulse rate within specified ranges
- Participants with normal renal function must have no significant disease or abnormal labs, normal renal function with eCLcr ≥ 90 mL/min, and matched weight, sex, and age to renal impairment participants
You will not qualify if you...
- Pregnant or lactating women
- Unlikely to comply with study requirements or complete the study
- Psychological or emotional issues limiting consent or compliance
- History of hypersensitivity to rupatadine or related compounds
- Lactose, galactose, or fructose intolerance
- Any acute or chronic disease jeopardizing safety or study validity
- Unsuitable veins for blood draws
- Participation in other clinical trials with experimental drugs recently
- History of angioedema
- Excessive caffeine or nicotine use near study time
- Positive urine drug or alcohol tests (with exceptions)
- History of organ transplant, stroke, seizures, or major neurological disorders
- Active cancer or myeloproliferative disease
- Use of creatine supplements
- Use of certain enzyme-modifying or interacting drugs prior to dosing
- Significant ECG abnormalities
- Recent significant blood loss
- For renal impairment participants: unstable or worsening renal function, dialysis requirement, or interfering medical conditions
- For normal renal function participants: clinically relevant abnormalities or conditions affecting drug absorption or metabolism, recent medication use affecting study outcomes
Research Team
D
Daniel Peris, PharmD
L
Laia Casas, MSc
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here