HealthyPhase 1BIOBINCT01124123
Oral Bioavailability of Bilastine
A Phase 1 study testing Bilastine in people with Healthy, run by Faes Farma, S.A. at 1 site in Spain.
Trial summary
The purpose of this study is to assess the absolute bioavailability of an oral bilastine formulation (test drug) compared to the endovenous administration of an IV bilastine formulation (control drug) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bilastine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of either sex aged from ≥ 18 to ≤ 35 years of age.
- Body mass index between 19 and 29 Kg/m2.
- Non smokers.
- Judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
- Provision of written informed consent to participate.
Who cannot join
- Pregnant or breast-feeding women or with a positive pregnancy test. Subjects who do not agree to use an adequate method of contraception during the study.
- Intake of another investigational medication in another clinical study within 4 months prior to the first study drug intake.
- Regular use of any prescribed medication including medicinal herbs or OTC medication within 4 weeks of dosing.
- A QTc> 430 ms in males and a QTc> 450 ms in females. A HR <55 bpm.
- Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
- Known allergy/hypersensitivity to the study drug or its inactive ingredients.
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- Any clinical conditions or circumstances that in the opinion of the investigator would make the subject unsuitable for the study (e.g., hepatic impairment, renal impairment, mental impairment, cardiac disease).
- Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
- Subjects who have taken metabolic or transporter inducers/inhibitors during the 3 months prior to inclusion in the study.
- Donation or loss of greater than 200 mL of blood within 12 weeks before entry to the study.
- Blood transfusion within the prior 6 months to inclusion.
- Ingestion of citrus fruits and cranberries or any fruit juice within 7 days prior to first dose of study medication.
- Known current alcohol or drug abuse.
- Excessive consumption of xanthine containing foods or drinks.
- Mentally disabled subjects or subjects who by official order have been institutionalised must be excluded from participation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investigacion Clinica. Clinica Universidad de Navarra
Pamplona, Navarre, 31008
About this study
Official title: Study to Assess Oral Bioavailability of Bilastine (Estudio de Biodisponibilidad Oral de Bilastina)
The purpose of this study is to assess the absolute bioavailability of an oral bilastine formulation (test drug) compared to the endovenous administration of an IV bilastine formulation (control drug) in healthy volunteers.
Read the detailed description
Single centre, open label, cross-over, randomised, controlled, single dose study. The primary endpoint is the determination of plasma concentrations versus time (17 samples per subject at various time intervals after dosing) in order to assess the oral bioavailability of bilastine in healthy volunteers. Therefore the primary pharmacokinetic variable will be the area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞). Additionally the following pharmacokinetic variables will also be assessed: Cmax, AUC 0-t, tmax, Ae, Clr, t1/2. Additional objectives are to describe the safety and tolerability of a single administration of oral and endovenous bilastine in healthy volunteers.
Twelve healthy volunteers will be included. Each volunteer will take in random order one single dose of 20 mg oral bilastine and 10 mg IV bilastine with a minimum washout period of 14 days between them.
Bilastine plasma concentrations will be measured using a liquid chromatography/mass mass spectrometry (LC/MS/MS) micro method
- Conditions
- Healthy
- Being tested
- Bilastine
- Keywords
- Pharmacokinetics, Oral bioavailability, absorption, AUC, Bioequivalence, Bioavailability study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
20 mg oral tablet
BilastineDrug
10 mg endovenous bilastine
| Study group | Role | What they receive |
|---|---|---|
| Bilastine 20 mg | Experimental | Single dose 20 mg bilastine oral tablet. Test drug Receives: Drug: Bilastine |
| Bilastine 10 mg | Active comparator | Single dose 10 mg Bilastine endovenous. Control drug Receives: Drug: Bilastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ).
Bilastine bioavailability will be obtained from the oral AUC 0-∞ / endovenous AUC 0-∞ quotient.
Measured: 17 blood draws performed at: 0,25 - 0,5- 0,75 - 1 - 1,25 - 1,5 - 1,75 - 2 - 2,5 - 3 - 4 - 5 - 7 - 12 - 24 - 48 and 72 hours post administration.
Secondary outcomes (2)
Additional pharmacokinetic variables: Cmax, AUC 0-t, tmax, Ae, CLr and t ½
- Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
- tmax: The time that Cmax was observed
- AUC 0-t: The area under the plasma concentration versus time curve from time zero to the last time point
- Ae: amount of accumulated unaltered drug in urine till the last time point
- Clr: Renal clearance
- t ½: Elimination halflife
Measured: 17 blood draws and urine collection during 72 hours post administration
Safety and tolerability of a single dose administration of oral and endovenous bilastine
Safety will be assessed during the study by monitoring adverse events (AEs), clinical laboratory test results (urinalysis, blood chemistry, and haematology), vital signs (including blood pressure, respiration, temperature, and heart rate, supine and standing), electrocardiogram (ECG) results, and abnormal findings upon physical examination.
Measured: A last Follow up visit will be performed 7 days after last drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belen Sadaba, MD, Principal investigator, Unidad de Investigacion Clinica. Clinica Universidad Navarra (CUN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124123
- Sponsor's protocol ID
- BILA 2909/BA
- Other IDs
- 2010-019049-25
- Acronym
- BIOBI
- Status last verified
- Sep 2012
- First submitted
- 13 May 2010
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodriguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54. doi: 10.2165/11317180-000000000-00000.
PubMed 19705924Lucero ML, Gonzalo A, Ganza A, Leal N, Soengas I, Ioja E, Gedey S, Jahic M, Bednarczyk D. Interactions of bilastine, a new oral H(1) antihistamine, with human transporter systems. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:8-17. doi: 10.3109/01480545.2012.682653.
PubMed 22616811Sadaba B, Gomez-Guiu A, Azanza JR, Ortega I, Valiente R. Oral availability of bilastine. Clin Drug Investig. 2013 May;33(5):375-81. doi: 10.1007/s40261-013-0076-y.
PubMed 23529786
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Oral Bioavailability of Bilastine (Estudio de Biodisponibilidad Oral de Bilastina)
- ClinicalTrials.gov ID
- NCT01124123
- Acronym / sponsor ID
- BIOBI / BILA 2909/BA
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Oral bioavailability, absorption, AUC, Bioequivalence, Bioavailability study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the absolute bioavailability of an oral bilastine formulation (test drug) compared to the endovenous administration of an IV bilastine formulation (control drug) in healthy volunteers.
Detailed description
Single centre, open label, cross-over, randomised, controlled, single dose study. The primary endpoint is the determination of plasma concentrations versus time (17 samples per subject at various time intervals after dosing) in order to assess the oral bioavailability of bilastine in healthy volunteers. Therefore the primary pharmacokinetic variable will be the area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞). Additionally the following pharmacokinetic variables will also be assessed: Cmax, AUC 0-t, tmax, Ae, Clr, t1/2. Additional objectives are to describe the safety and tolerability of a single administration of oral and endovenous bilastine in healthy volunteers.
Twelve healthy volunteers will be included. Each volunteer will take in random order one single dose of 20 mg oral bilastine and 10 mg IV bilastine with a minimum washout period of 14 days between them.
Bilastine plasma concentrations will be measured using a liquid chromatography/mass mass spectrometry (LC/MS/MS) micro method
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilastine 20 mg | Experimental | Drug: BilastineSingle dose 20 mg bilastine oral tablet. Test drug |
| Bilastine 10 mg | Active comparator | Drug: BilastineSingle dose 10 mg Bilastine endovenous. Control drug |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers of either sex aged from ≥ 18 to ≤ 35 years of age.
- Body mass index between 19 and 29 Kg/m2.
- Non smokers.
- Judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
Key exclusion criteria (15 listed)
- Pregnant or breast-feeding women or with a positive pregnancy test. Subjects who do not agree to use an adequate method of contraception during the study.
- Intake of another investigational medication in another clinical study within 4 months prior to the first study drug intake.
- Regular use of any prescribed medication including medicinal herbs or OTC medication within 4 weeks of dosing.
- A QTc> 430 ms in males and a QTc> 450 ms in females. A HR <55 bpm.
- Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilastine20 mg oral tablet | Drug | Bilastine 20 mg |
| Bilastine10 mg endovenous bilastine | Drug | Bilastine 10 mg |
Primary outcome
The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ).
Time frame: 17 blood draws performed at: 0,25 - 0,5- 0,75 - 1 - 1,25 - 1,5 - 1,75 - 2 - 2,5 - 3 - 4 - 5 - 7 - 12 - 24 - 48 and 72 hours post administration.
Bilastine bioavailability will be obtained from the oral AUC 0-∞ / endovenous AUC 0-∞ quotient.
2 secondary outcomes
Additional pharmacokinetic variables: Cmax, AUC 0-t, tmax, Ae, CLr and t ½
Time frame: 17 blood draws and urine collection during 72 hours post administration
Safety and tolerability of a single dose administration of oral and endovenous bilastine
Time frame: A last Follow up visit will be performed 7 days after last drug intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Background: PubMed 19705924Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodriguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54. doi: 10.2165/11317180-000000000-00000.
- Background: PubMed 22616811Lucero ML, Gonzalo A, Ganza A, Leal N, Soengas I, Ioja E, Gedey S, Jahic M, Bednarczyk D. Interactions of bilastine, a new oral H(1) antihistamine, with human transporter systems. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:8-17. doi: 10.3109/01480545.2012.682653.
- Derived from this study: PubMed 23529786Sadaba B, Gomez-Guiu A, Azanza JR, Ortega I, Valiente R. Oral availability of bilastine. Clin Drug Investig. 2013 May;33(5):375-81. doi: 10.1007/s40261-013-0076-y.
- Clinical Trials and Medical Research page. Clinica Universidad Navarra (CUN)Link provided by the sponsor.
- Clinical Pharmacology Department. Clinica Universidad Navarra (CUN)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belen Sadaba, MD principal investigator
Unidad de Investigacion Clinica. Clinica Universidad Navarra (CUN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bilastine in people with Healthy, run by Faes Farma, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ). (time frame: 17 blood draws performed at: 0,25 - 0,5- 0,75 - 1 - 1,25 - 1,5 - 1,75 - 2 - 2,5 - 3 - 4 - 5 - 7 - 12 - 24 - 48 and 72 hours post administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124123, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.