This is a Phase I study in helathy subjects. No condition is being treated. The IMP is approved for symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).
Conditions
Interventions
Trade Name: Rupafin 10mg tablets
Product Name: Rupafin tablets 10mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
J. Uriach y Compañía, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female Japanese subject, aged 20 - 45 years, inclusive, at screening. Japanese subjects must meet the following criteria: i) born in Japan to both Japanese parents and grandparents; ii) lived less than 5 years outside of Japan; iii) no significant change in lifestyle, including diet, since leaving Japan 2. Subject has a Body Mass Index (BMI) of 18 – 25 kg/m2 inclusive at screening. 3. Subjects must agree to use acceptable methods of contraception: If female, subjects of childbearing potential must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 3 months following administration of the last treatment or dose of study medication as outlined in the protocol. Male subjects must utilise at least one of the methods outlined in the protocol. 4. All subjects included in the study must meet the ECG screening selection criteria. ECG criteria to be signed off for inclusion by a cardiologist (if applicable). 5. Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be prohibited from participation in this clinical study if they meet any of the following criteria at the screening and/or admission visits: 1. Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion. 2. Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission. 3. Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis. 4. History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric or other disease. 5. Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive], Hepatitis C antibodies (anti-HCV), and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies, (anti-HIV 1/2). 6. Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol breath test at screening and on admission (Day -1). 7. History or clinical evidence of alcohol or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 21 units (Using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms. 8. Mentally handicapped. 9. Participation in a drug trial within 90 days prior to first drug administration. 10. Use of any medication (including over-the-counter (OTC) medication) within 2 weeks prior to admission (Day -1) or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods. Single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the trial objectives. 11. Use of any substance inhibiting CYP3A4 enzymes within 2 weeks prior to admission (Day -2). 12. Donation of more than 500 mL of blood within 90 days prior to drug administration. 13. Subjects who smoke more than 10 cigarettes or equivalent amount of tobacco per day and/or who cannot stop smoking for the duration of the study whilst in the CPU. 14. Treatment with herbal supplements during the 7 days prior to dosing, or use of vitamins during 48 hours prior to admission to the CPU (Day -2). 15. Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol. 16. Legal incapacity or limited legal capacity at screening. 17. Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of RUPATADINE following single and multiple oral administrations to healthy Japanese subjects.;Secondary Objective: 1. To investigate the pharmacokinetics (PK) of RUPATADINE and its two main metabolites desloratadine (UR 12790) and hydroxylatedesloratadine (UR 12788) in plasma and urine (including free and conjugated UR12788) following single and multiple dosing of RUPATADINE once daily in healthy Japanese subjects. 2. To investigate the pharmacodynamic (PD) activity of RUPATADINE by assessment of dose on cognitive function. 3. To measure the effect of RUPATADINE on ECG parameters.;Primary end point(s): Drug plasma levels Pharmacodynamic (cognitive) assessment ECG Adverse event monitoring;Timepoint(s) of evaluation of this end point: Drug plasma levels from day -1 through day 11 (6 days after last dose) Pharmacodynamic (cognitive) assessment day -2, -1, 1 and 5 ECG day -1, 1 and 5 Adverse event monitoring daily from day -2 through day 11 (6 days after last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trial Manager
J. Uriach y Compañía, S.A.
Outcome results
None listed