Clinical Trial Results:
A multicentre, open-label clinical trial to assess plasma levels and safety of bilastine in children from 2 to 5 years of age with seasonal and/or perennial allergic rhinoconjunctivitis or urticaria
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Summary
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EudraCT number |
2021-003011-26 |
Trial protocol |
SK LT PL |
Global end of trial date |
21 Apr 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Mar 2024
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First version publication date |
21 Mar 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BILA-4021/PED
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
FAES FARMA, S.A.
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Sponsor organisation address |
Avenida Autonomía 10, Leioa (Bizkaia) , Spain, 48940
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Public contact |
Clinical Research Derpartment, FAES FARMA S.A., clinical_rd@faes.es
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Scientific contact |
Clinical Research Derpartment, FAES FARMA S.A., clinical_rd@faes.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jun 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Apr 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Apr 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To obtain bilastine plasma concentrations after the administration of multiple oral doses over a treatment period of 7 (+3) days in children between the ages of 2 and 5 years old with seasonal and/or perennial allergic rhinoconjunctivitis (SAR/PAR) or urticaria.
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Protection of trial subjects |
The trial will be conducted in compliance with this protocol, by the trial personnel, who are qualified by education, training, and experienced in their roles, with adherence to Good Clinical Practice (GCP), the applicable regulatory requirements, and ethical principles based on the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Dec 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 6
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Country: Number of subjects enrolled |
Slovakia: 19
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Country: Number of subjects enrolled |
Lithuania: 14
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Worldwide total number of subjects |
39
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EEA total number of subjects |
39
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
39
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
39 subjects were enrolled in 7 active sites in 3 European countries: Lithuania (2 sites), Poland (1 site) and Slovakia (4 sites), 38 subjects were randomised. | ||||||||||||||
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Pre-assignment
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Screening details |
Subjects who met all the inclusion criteria and none of the exclusion criteria. 39 subjects were enrolled to the trial. 1 subject was a screening failure, for 1 subject consent was withdrawn before IMP intake. | ||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
39 | ||||||||||||||
Number of subjects completed |
38 | ||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Screening failures: 1 | ||||||||||||||
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Period 1
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Period 1 title |
Baseline Period
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Overall - Bilastine | ||||||||||||||
Arm description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||||||||||||||
Arm type |
Open-label trial with only one treatment arm | ||||||||||||||
Investigational medicinal product name |
Bilastine orodispersible tablets 10 mg
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Investigational medicinal product code |
Bilastine
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Other name |
Bilaxten
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects received 10 mg of bilastine orally, once daily, preferably in the morning and at the same time every day for 7 (+3) days (all subjects) or 14 (+6) days (based on investigator’s decision). The IMP was taken under fasting conditions, 1 hour before or 2 hours after intake of food. In case fruits, fruit juices, meals containing fruits or soft drinks were consumed, the medication was recommended to be taken either 3 hours before or 3 hours afterwards. The details of IMP intake were described in the IMP intake instructions.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Number of subjects in the baseline period are defined as subjects who met all the inclusion criteria and none of the exclusion criteria. 39 subjects were enrolled to the trial. 1 subject was a screening failure |
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Period 2
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Period 2 title |
Overall Treatment Period
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Is this the baseline period? |
No | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Overall - Bilastine | ||||||||||||||
Arm description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||||||||||||||
Arm type |
Open-label trial with only one treatment arm | ||||||||||||||
Investigational medicinal product name |
Bilastine orodispersible tablets 10 mg
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Investigational medicinal product code |
Bilastine
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Other name |
Bilaxten
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects received 10 mg of bilastine orally, once daily, preferably in the morning and at the same time every day for 7 (+3) days (all subjects) or 14 (+6) days (based on investigator’s decision). The IMP was taken under fasting conditions, 1 hour before or 2 hours after intake of food. In case fruits, fruit juices, meals containing fruits or soft drinks were consumed, the medication was recommended to be taken either 3 hours before or 3 hours afterwards. The details of IMP intake were described in the IMP intake instructions.
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Period 3
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Period 3 title |
Completion Period
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Is this the baseline period? |
No | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Overall - Bilastine | ||||||||||||||
Arm description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||||||||||||||
Arm type |
Open-label trial with only one treatment arm | ||||||||||||||
Investigational medicinal product name |
Bilastine orodispersible tablets 10 mg
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Investigational medicinal product code |
Bilastine
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Other name |
Bilaxten
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects received 10 mg of bilastine orally, once daily, preferably in the morning and at the same time every day for 7 (+3) days (all subjects) or 14 (+6) days (based on investigator’s decision). The IMP was taken under fasting conditions, 1 hour before or 2 hours after intake of food. In case fruits, fruit juices, meals containing fruits or soft drinks were consumed, the medication was recommended to be taken either 3 hours before or 3 hours afterwards. The details of IMP intake were described in the IMP intake instructions.
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Period 4
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Period 4 title |
Follow-Up Period
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Is this the baseline period? |
No | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Overall - Bilastine | ||||||||||||||
Arm description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||||||||||||||
Arm type |
Open-label trial with only one treatment arm | ||||||||||||||
Investigational medicinal product name |
Bilastine orodispersible tablets 10 mg
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Investigational medicinal product code |
Bilastine
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Other name |
Bilaxten
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
All subjects received 10 mg of bilastine orally, once daily, preferably in the morning and at the same time every day for 7 (+3) days (all subjects) or 14 (+6) days (based on investigator’s decision). The IMP was taken under fasting conditions, 1 hour before or 2 hours after intake of food. In case fruits, fruit juices, meals containing fruits or soft drinks were consumed, the medication was recommended to be taken either 3 hours before or 3 hours afterwards. The details of IMP intake were described in the IMP intake instructions.
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Baseline characteristics reporting groups
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Reporting group title |
Overall - Bilastine
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Reporting group description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The safety set (SAF) was defined as all subjects who received at least one dose of IMP.
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Subject analysis set title |
PK-Set
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The PK set was defined as all subjects who received at least one dose of IMP and had at least one plasma concentration result.
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Subject analysis set title |
PK group 1
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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Subject analysis set title |
PK group 2
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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Subject analysis set title |
PK group 3
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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End points reporting groups
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Reporting group title |
Overall - Bilastine
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Reporting group description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||
Reporting group title |
Overall - Bilastine
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Reporting group description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||
Reporting group title |
Overall - Bilastine
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Reporting group description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||
Reporting group title |
Overall - Bilastine
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Reporting group description |
Children aged 2 to 5 years with allergic rhinoconjunctivitis or urticaria. All eligible subjects were treated with a dose of 10 mg bilastine orodispersible tablets once daily and were randomised in a 1:1:1 ratio to one of 3 PK blood sampling groups, stratified by age group (≥ 2 to < 4 years of age; ≥ 4 to ≤ 5 years of age). | ||
Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety set (SAF) was defined as all subjects who received at least one dose of IMP.
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Subject analysis set title |
PK-Set
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
The PK set was defined as all subjects who received at least one dose of IMP and had at least one plasma concentration result.
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Subject analysis set title |
PK group 1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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Subject analysis set title |
PK group 2
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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Subject analysis set title |
PK group 3
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects of Safety Set set were randomly assigned to one of the 3 pharmacokinetic (PK) blood sampling groups, the randomisation ratio was 1:1:1 with a stratification by age group (children from ≥ 2 to < 4 years of age and children from ≥ 4 to ≤ 5 years of age).
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End point title |
Bilastine plasma concentrations at 0.25 h [1] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 0.25 hours after intake is stated.
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End point type |
Primary
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End point timeframe |
At 0.25h
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Bilastine plasma concentrations at 0.5 h [2] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 0.5 hours after intake is stated.
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End point type |
Primary
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End point timeframe |
At 0.5 h
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Bilastine plasma concentrations at 1 h [3] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 1 hour after intake is stated.
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End point type |
Primary
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End point timeframe |
At 1 h.
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Bilastine plasma concentrations at 2 h [4] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 2 hours after intake is stated.
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End point type |
Primary
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End point timeframe |
At 2 h.
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Bilastine plasma concentrations at 4 h [5] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 4 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 4 h.
|
||||||||
| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 6 h [6] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 6 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 6 h.
|
||||||||
| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 12 h [7] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the maximum value (ng/ml) for bilastine plasma concentrations at 12 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 12 h.
|
||||||||
| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 0.25 h [8] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 0.25 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 0.25 h.
|
||||||||
| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 0.5 h [9] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 0.5 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 0.5 h.
|
||||||||
| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 1 h [10] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 1 hour after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 1 h.
|
||||||||
| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 2 h [11] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 2 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 2 h.
|
||||||||
| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 4 h [12] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 4 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 4 h.
|
||||||||
| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 6 h [13] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 6 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 6 h.
|
||||||||
| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Bilastine plasma concentrations at 12 h [14] | ||||||||
End point description |
When comparing the individual subject’s data, highest bilastine plasma concentration values were observed 0.5, 1 and 2 hours after IMP intake (up to 583.35 ng/mL, 634.91 ng/mL and 375.81 ng/mL, respectively) while values decreased at 4, 6 and 12 hours after IMP intake to individual values below 100 ng/mL except for one subject with 154.20 ng/mL after 4 hours.
Here the minimum value (ng/ml) for bilastine plasma concentrations at 12 hours after intake is stated.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 12 h.
|
||||||||
| Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint of this trial was only to assess the values for bilastine plasma concentrations. A PK analysis including PK modelling will be performed out of scope of this trial and results will be provided as a separate report. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
In this clinical trial all untoward events with onset or worsening after the first intake of IMP until the end of the follow-up period will be defined as TEAEs.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
In this clinical trial all untoward events with onset or worsening after the first intake of IMP until the end of the follow-up period will be defined as TEAEs.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall - Bilastine x Safety Set
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in the Safety Set treated with Bilastine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
