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

Recruiting now · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT06708520

Run by

Noucor Health S.A.

People needed

48

Starts

2022-11-21

Expected to finish

2025-07-01

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants with normal renal function and participants with mild, moderate, or severe renal impairment who meet the following criteria will be considered eligible to participate in the clinical study:
• Participant understands the study procedures and agrees to participate in the study by giving written informed consent prior to any study-mandated procedure.
• Able to communicate well with the Investigator, to understand and comply with the study requirements.
• Willing to comply with study restrictions stated in Section 5.3 (lifestyle considerations).
• Male or female Caucasian subjects, between 18 and 75 years (inclusive) of age.
• Body mass index (BMI) is between 18 to 35 kg/m2 at Screening.
• Women of childbearing potential (WoCBP) must have a negative serum pregnancy test at Screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use (from 30 days prior to dosing, during the entire study, and for at least 30 days after dosing), a highly effective method of contraception (i.e., failure rate of < 1%) (Section 10.4 [Appendix 4]). Such methods include:
• Hormonal contraceptives: combined (estrogen- and progesterone-containing) contraception associated with inhibition of ovulation using oral, intravaginal, or transdermal route of administration.
• Note: If a hormonal contraceptive is used, it must be initiated at least 30 days before dosing.
• Intrauterine device.
• Intrauterine hormone-releasing system.
• Bilateral tubal occlusion.
• Vasectomized partner, provided that the partner is the sole sexual partner and that the vasectomized partner has received medical assessment of the surgical success.
• Sexual abstinence, defined as refraining from heterosexual intercourse from 30 days prior to dosing up to at least 30 days after dosing, if this is the preferred and usual lifestyle of the subject.
• WoCBP must also agree not to donate ova from the time of informed consent until 30 days after dosing
• Women of non-childbearing potential (WoNCBP), i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicular stimulating hormone [FSH] test), with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, uterine agenesis (Section 10.4 [Appendix 4]).
• Male participants are infertile, vasectomized (who has received medical assessment of the surgical success) or must agree to abstain from, or to use a condom, during heterosexual intercourse with a woman of childbearing potential (Section 10.4 [Appendix 4]).
• Male participants must agree not to donate sperm, from the time of informed consent until 30 days after dosing.
• Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis Cvirus antibodies (anti-HCVAb).
• Participant agrees to refrain from consuming grapefruit juice, grapefruits, and grapefruitcontaining products from at least 7 days before the dose administration, and until the EOS Visit.
• Able to tolerate venipuncture
• For participants with mild, moderate, or severe renal impairment, the following criteria must be met in addition:
• Participants with impaired renal function should be hemodynamically stable.
• Diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal impairment.
• Estimated GFR must range from:

You may not qualify if…

• Participants with normal renal function and participants with mild, moderate, or severe renal impairment who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:
• Pregnant or lactating women.
• Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for the EOS Visit and improbability of completing the clinical study.
• Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the participant to comply with the protocol requirements
• History of hypersensitivity to rupatadine, desloratadine or any of the excipients, or to medicinal products with similar chemical structures.
• History of clinically significant lactose, galactose, or fructose intolerance.
• Any clinically relevant acute or chronic disease which could jeopardize the safety of the participant or impact the validity of the study results.
• Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
• Participation in another clinical trial with an experimental drug within 2 months or 5 halflives (whichever is longer) before the Screening or in more than 2 clinical studies within 1 year prior to Screening.
• History or presence of clinically significant angioedema.
• Use of caffeine-containing beverages exceeding 800 mg per day (Section 5.3.2) at Screening.
• Nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) from 48 h prior to Baseline (Day -1) until discharge from confinement (Day 2).
• Positive test result for urine alcohol and drugs of abuse (amphetamines, benzodiazepines, cannabinoids, cocaine and opiates) at Screening and Baseline.
• Note: Subjects receiving stable treatment of methadone and benzodiazepines will be allowed to be enrolled in the study even if the urine drug screen test is positive.
• History of heart, kidney or liver transplantation.
• History of stroke, chronic seizures, or major neurological disorder.
• Active malignant neoplastic disease or carcinoma (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.
• Intake of any creatine supplement from Screening to EOS.
• Use of any of the following 2 weeks prior to investigational medicinal product (IMP) administration or 5 half-lives, whichever is longer:
• Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism (e.g., azole antifungals [ketoconazole, itraconazole, fluconazole, Posaconazole, voriconazole], macrolide antibiotics [erythromycin, clarithromycin], diltiazem, human immunodeficiency virus (HIV) protease inhibitors, nefazodone, rifampicin, phenytoin, dexamethasone, troglitazone, and barbiturates)
• CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride)
• Desloratadine
• Clinically significant abnormalities on ECG repolarization (QTcF > 450 ms in males and >470 ms in females) at Screening.
• Loss of 250 mL or more blood within 3 months prior to screening.
• For participants with mild, moderate or severe renal impairment the additional criteria must not be met:

Where it is running

• Centro Hospitalar De Vila Nova De Gaia Espinho — Gaia, Portugal (enrolling)
• Hospital Pedro Hispano — Matosinhos Municipality, Portugal (enrolling)
• Blueclinical Investigacao E Desenvolvimento Em Saude Lda. — Porto, Portugal (enrolling)
• Hospital Universitari Germans Trias I Pujol — Badalona, Spain (enrolling)
• Municipal Institute Of Medical Investigation — Barcelona, Spain (enrolling)
• Hospital De La Santa Creu I Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario De La Princesa — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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