Clinical Trials Register

Summary
EudraCT Number:	2012-004900-37
Sponsor's Protocol Code Number:	DC05/RUP/I/13
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-11-13
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2012-004900-37

A.3

Full title of the trial

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel group study to assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral Rupatadine in Healthy Japanese Subjects after Single and Multiple Ascending Doses

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to investigate the effects, safety and side effects of rupatidine in Japanese subjects when given at increasing doses, and to look at the way that the drug is absorbeed and eliminated in the body.

A.4.1

Sponsor's protocol code number

DC05/RUP/I/13

A.5.4

Other Identifiers

Name:

Richmond Pharmacology Study Number

Number:

C11050

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	J. Uriach y Compañía, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	J. Uriach y Compañía, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	J. Uriach y Compañía, S.A.
B.5.2	Functional name of contact point	Clinical Trial Manager
B.5.3	Address:
B.5.3.1	Street Address	Avinguda Camí Reial, 51-57, 08184 Palau-solità i Plegamans
B.5.3.2	Town/ city	Barcelona
B.5.3.4	Country	Spain
B.5.4	Telephone number	34938630278
B.5.6	E-mail	eva.santamaria@uriach.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Rupafin 10mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	J. Uriach & Cía., S.A.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Rupafin tablets 10mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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).

E.1.1.1

Medical condition in easily understood language

Not applicable

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the safety and tolerability of RUPATADINE following single and multiple oral administrations to healthy Japanese subjects.

E.2.2

Secondary objectives of the trial

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.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.

E.5 End points

E.5.1

Primary end point(s)

Drug plasma levels
Pharmacodynamic (cognitive) assessment
ECG
Adverse event monitoring

E.5.1.1

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)

E.5.2

Secondary end point(s)

not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

pharmacokinetics

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

last visit last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-20

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