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

Inclusion Criteria

• •Participants with normal hepatic function and participants with mild, moderate, or severe hepatic impairment who meet the following criteria will be considered eligible to participate in the clinical study:
• •1. Participant understands the study procedures and agrees to participate in the study by giving written informed consent prior to any study-mandated procedure.
• •2. Able to communicate well with the Investigator, to understand and comply with the study requirements.
• •3. Willing to comply with study restrictions stated in Section 5.3 (lifestyle considerations).
• •4. Male or female Caucasian subject, between 18 and 75 years (inclusive) of age.
• •5. Body mass index (BMI) is between 18 to 35 kg/m2 at Screening.
• •6. 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
• •7. 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 0 \[Appendix 4\]).
• •8. 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 0 \[Appendix 4\]).
• •9. Male participants must agree not to donate sperm, from the time of informed consent until 30 days after dosing.
• •10. 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.
• •11. Able to tolerate venipuncture.
• •12. No clinically relevant abnormalities on rest vital signs.
• •13. No clinically relevant abnormalities on 12-lead ECG.
• •For participants with normal hepatic function the following criteria must be met in addition:
• •14. No clinically relevant diseases captured in medical history at Screening.
• •15. No clinically relevant abnormalities on physical examination and Screening and Baseline.
• •16. No clinically relevant abnormalities on clinical laboratory tests at Screening.
• •17. Weight within ±15% to his/her matched participant(s) enrolled in the study.
• •18. Biological sex matched to his/her matched participant(s) enrolled in the study.
• •19. Age within ±10 years to his/her matched participant(s) enrolled in the study.
• •20. Normal Blood Pressure (BP) measured on the same arm, after 5 min in the supine position at Screening and Baseline defined as:
• •* Systolic Blood Pressure (SBP) 90-140 mmHg, Diastolic Blood Pressure (DBP) 60-90 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects \< 65 years of age.
• •* SBP 95-160 mmHg, DBP 65-95 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects ≥ 65 years of age.
• •For participants with mild, moderate, or severe hepatic impairment the following criteria must be met in addition:
• •21. No clinically relevant abnormalities on clinical laboratory tests at Screening, except for those related to liver cirrhosis.
• •22. SBP 90-160 mmHg, DBP 60-95 mmHg, and pulse rate 60-100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and Baseline.
• •23. Participant has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic impairment, defined by Child Pugh Classification, with features of cirrhosis due to any etiology.
• •24. Child-Pugh scale score (see Section 4.2 for Child-Pugh Classification) from 5 to 6 (mild hepatic impairment), 7 to 9 (moderate hepatic impairment) or 10 to 15 (severe hepatic impairment) at the Screening Visit.
• •25. Stable concomitant medications for at least 21 days prior to dosing and up to the EOS visit.