Actively Recruiting
Pharmacokinetics and Safety of Rupatadine in Participants With Renal Impairment Compared to Control Participants
Led by Noucor Health S.A. · Updated on 2025-05-28
48
Participants Needed
7
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Participants must understand and agree to study procedures with written consent.
- Able to communicate well and comply with study requirements.
- Willing to follow lifestyle restrictions during the study.
- Male or female Caucasian aged 18 to 75 years inclusive.
- Body mass index between 18 and 35 kg/m2 at screening.
- Women of childbearing potential must have negative pregnancy tests and use effective contraception starting 30 days before dosing through 30 days after dosing.
- Women not of childbearing potential include postmenopausal or surgically sterile women.
- Male participants must be infertile, vasectomized, or use contraception during intercourse with women of childbearing potential.
- Negative tests for HIV, Hepatitis B, and Hepatitis C.
- Agree to avoid grapefruit products from 7 days before dosing until study end.
- Able to tolerate blood draws.
- For renal impairment group: stable chronic renal impairment for over 6 months, hemodynamically stable, and estimated GFR within specified ranges for mild, moderate, or severe impairment.
- Stable medications for at least 21 days before dosing.
- Blood pressure and pulse within specified ranges at screening and baseline.
- For normal renal function group: no significant diseases or abnormalities, normal kidney function confirmed by creatinine clearance ≥ 90 mL/min.
- Weight, age, and sex matched to renal impairment group participants.
- Normal blood pressure according to age-specific ranges.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Unlikely to comply with study protocol or complete study visits.
- Psychological or emotional disorders that affect consent or compliance.
- History of allergy to rupatadine, desloratadine, or similar substances.
- Clinically significant intolerance to lactose, galactose, or fructose.
- Any serious acute or chronic illness that may affect safety or study results.
- Unsuitable veins for blood sampling.
- Participation in another experimental drug trial within 2 months or 5 half-lives before screening.
- History of angioedema.
- High caffeine intake over 800 mg per day at screening.
- Nicotine use from 48 hours before baseline until discharge.
- Positive urine tests for alcohol or drugs of abuse (except stable methadone or benzodiazepine treatment).
- History of organ transplantation.
- History of stroke, seizures, or major neurological disorders.
- Active cancer or blood disorders.
- Use of creatine supplements from screening to study end.
- Use of enzyme-modifying drugs, CYP3A4 substrates with narrow therapeutic index, or desloratadine within 2 weeks or 5 half-lives before dosing.
- Abnormal ECG repolarization at screening.
- Significant blood loss within 3 months before screening.
- For renal impairment group: fluctuating or worsening renal function, need for dialysis, or conditions interfering with drug absorption or study completion.
- For normal renal function group: clinically relevant abnormalities in any organ system or conditions affecting drug metabolism or absorption.
- Use of medications affecting study outcomes within 14 days before dosing, except contraceptives and hormone therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Centro Hospitalar De Vila Nova De Gaia Espinho
Gaia, Portugal, 4434-502
Actively Recruiting
2
Hospital Pedro Hispano
Matosinhos Municipality, Portugal, 4450-113
Actively Recruiting
3
Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, Portugal, 4250-449
Actively Recruiting
4
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 8916
Actively Recruiting
5
Municipal Institute Of Medical Investigation
Barcelona, Spain, 08003
Actively Recruiting
6
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
7
Hospital Universitario De La Princesa
Madrid, Spain, 28006
Actively Recruiting
Research Team
D
Daniel Peris, PharmD
CONTACT
L
Laia Casas, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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