HealthyPhase 1NCT00419783
A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine
A Phase 1 study testing bilastine, Bilastine & Ketoconazole and Moxifloxacin in people with Healthy, run by Faes Farma, S.A. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bilastine, Bilastine & Ketoconazole and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2006
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results
Who cannot join
- Clinically significant medical condition
- Clinically significant history of ECG abnormalities or family history of QTc interval syndrome
- Use of tobacco and/or nicotine products >3 months prior to screening
- Use of any prescription medications within 14 days prior to screening
- Use of over the counter medications (including herbal products) within 7 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.
Read the detailed description
This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.
- Conditions
- Healthy
- Being tested
- bilastine, Bilastine & Ketoconazole, Moxifloxacin, Placebo
- Keywords
- Allergic rhinitis, Urticaria
- Medical subject headings
- Rhinitis, Allergic, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilastineDrug
20 mg tablets.
BilastineDrug
100 mg (5 tablets of 20 mg)
Bilastine & KetoconazoleDrug
1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
MoxifloxacinDrug
1 capsule containing moxifloxacin 400 mg tablet
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bilastine 20 mg Receives: Drug: bilastine |
| 2 | Experimental | Bilastine 100 mg Receives: Drug: Bilastine |
| 3 | Active comparator | Bilastine 20 mg + Ketoconazole 400 mg Receives: Drug: Bilastine & Ketoconazole |
| 4 | Active comparator | Moxifloxacin 400 mg Receives: Drug: Moxifloxacin |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc Interval prolongation
Measured: 4 days
Secondary outcomes (1)
vital signs, adverse events, and routine clinical laboratory tests
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2006
- Study completionDec 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark J Allison, MD, Principal investigator, MDS Pharma Services (US)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419783
- Sponsor's protocol ID
- 459-09
- Other IDs
- BILA-459/09, AA24101
- Status last verified
- Apr 2012
- First submitted
- 8 Jan 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11.
PubMed 21831011Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E, Roupe K, Blanco N, Wheeler W. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol. 2012 Jun;52(6):893-903. doi: 10.1177/0091270011407191. Epub 2011 Jun 3.
PubMed 21642470Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig. 2012 May 1;32(5):339-51. doi: 10.2165/11599270-000000000-00000.
PubMed 22393898
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00419783
- Acronym / sponsor ID
- 459-09
- Conditions
- Healthy
- Keywords
- Allergic rhinitis, Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Jan 2007 (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 evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.
Detailed description
This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bilastineBilastine 20 mg |
| 2 | Experimental | Drug: BilastineBilastine 100 mg |
| 3 | Active comparator | Drug: Bilastine & KetoconazoleBilastine 20 mg + Ketoconazole 400 mg |
| 4 | Active comparator | Drug: MoxifloxacinMoxifloxacin 400 mg |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results
Key exclusion criteria (5 listed)
- Clinically significant medical condition
- Clinically significant history of ECG abnormalities or family history of QTc interval syndrome
- Use of tobacco and/or nicotine products >3 months prior to screening
- Use of any prescription medications within 14 days prior to screening
- Use of over the counter medications (including herbal products) within 7 days prior to screening
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 tablets. | Drug | 1 |
| Bilastine100 mg (5 tablets of 20 mg) | Drug | 2 |
| Bilastine & Ketoconazole1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet | Drug | 3 |
| Moxifloxacin1 capsule containing moxifloxacin 400 mg tablet | Drug | 4 |
| PlaceboPlacebo tablets | Drug | 5 |
Primary outcome
QTc Interval prolongation
Time frame: 4 days
1 secondary outcome
vital signs, adverse events, and routine clinical laboratory tests
Time frame: 4 days
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 5 Apr 2012.
- Background: PubMed 21831011Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11.
- Results publication: PubMed 21642470Tyl B, Kabbaj M, Azzam S, Sologuren A, Valiente R, Reinbolt E, Roupe K, Blanco N, Wheeler W. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol. 2012 Jun;52(6):893-903. doi: 10.1177/0091270011407191. Epub 2011 Jun 3.
- Results publication: PubMed 22393898Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig. 2012 May 1;32(5):339-51. doi: 10.2165/11599270-000000000-00000.
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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.
Mark J Allison, MD principal investigator
MDS Pharma Services (US)
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, Bilastine & Ketoconazole and Moxifloxacin in people with Healthy, run by Faes Farma, S.A. at 1 site in United States.
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 1 inclusion and 5 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 5 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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?
QTc Interval prolongation (time frame: 4 days). 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 NCT00419783, 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 5 Apr 2012.