HealthyPhase 1NCT00572611
Human Mass Balance Study With Bilastine
A Phase 1 study testing [14C]-bilastine in people with Healthy, run by Faes Farma, S.A. at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-bilastine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2007to Dec 2007
- 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically important abnormal physical findings.
- No clinically significant abnormalities in the results of laboratory evaluation.
- Normal ECG.
- Normal supine blood pressure and heart rate.
- Body weight between 50 and 100 kg and body mass index between 18 and 30 kg/m2.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
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- Provision of written informed consent to participate.
- Subjects must agree to use an adequate method of contraception during the study and for 12 weeks after dosing.
- Subjects must have a negative urine screen for drugs of abuse.
- Subjects must have a regular bowel habit.
Who cannot join
- Administration of any IMP within 12 weeks before entry to the study.
- Use of any prescribed medication or St John's Wort within 14 days or OTC medication within 5 days of dosing.
- 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.
- History of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week.
- Presence or history of allergy requiring treatment.
- Hayfever is allowed unless it is active or has required treatment within the previous 2 months.
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- Donation or loss of greater than 400 mL of blood within 12 weeks before entry to the study.
- Serious adverse reaction or serious hypersensitivity to any drug.
- Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
- Administration of radiolabelled substances or exposure to significant radiation (eg serial x-ray or CT scans, barium meal etc) within the past 12 months.
- Any ECG abnormality at screening (including QTc intervals of >430 ms).
- Past medical history of clinically significant ECG abnormalities, or a family history of a prolonged QT interval syndrome.
- Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
- Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine, etc.) within 2 months prior to or during the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Laboratories Clinical Services Ltd, Origo Centre
Riccarton, Edinburgh, EH14 4AP
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers
The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine
Read the detailed description
Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.
- Conditions
- Healthy
- Being tested
- [14C]-bilastine
- Keywords
- Mass Balance, Metabolism, Absorption, Excretion, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-bilastineDrug
Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Single oral dose of 20 mg [14C]-bilastine Receives: Drug: [14C]-bilastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood and plasma concentrations of total radioactivity and parent drug
Measured: 168-216 h after dosing, depending on the radioactivity recovery
Urine and faecal recovery of total radioactivity
Measured: 168-216 h after dosing, depending on the radioactivity recovery
Characterisation and identification of metabolites in plasma, urine and faeces
Measured: 168-216 h after dosing, depending on the radioactivity recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd, MDS Pharma Services Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Stuart J Mair, MD, Principal investigator, Syneos HealthLindsay McGregor, Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572611
- Sponsor's protocol ID
- BILA 459-13
- Other IDs
- EudraCT Number: 2007-003373-12, CR Study Number: 186781
- Status last verified
- Sep 2012
- First submitted
- 12 Dec 2007
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucero ML, Gonzalo A, Mumford R, Betanzos M, Alejandro A. An overview of bilastine metabolism during preclinical investigations. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:18-24. doi: 10.3109/01480545.2012.682651.
PubMed 22616812Lucero ML, Patterson AB. Whole-body tissue distribution of total radioactivity in rats after oral administration of [(1)(4)C]-bilastine. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:1-7. doi: 10.3109/01480545.2012.682650.
PubMed 22616810
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
- A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00572611
- Acronym / sponsor ID
- BILA 459-13
- Conditions
- Healthy
- Keywords
- Mass Balance, Metabolism, Absorption, Excretion, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd, MDS Pharma Services Switzerland AG
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Dec 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 primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine
Detailed description
Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: [14C]-bilastineSingle oral dose of 20 mg [14C]-bilastine |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- No clinically important abnormal physical findings.
- No clinically significant abnormalities in the results of laboratory evaluation.
- Normal ECG.
- Normal supine blood pressure and heart rate.
- Body weight between 50 and 100 kg and body mass index between 18 and 30 kg/m2.
Key exclusion criteria (14 listed)
- Administration of any IMP within 12 weeks before entry to the study.
- Use of any prescribed medication or St John's Wort within 14 days or OTC medication within 5 days of dosing.
- 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.
- History of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week.
- Presence or history of allergy requiring treatment.
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 |
|---|---|---|
| [14C]-bilastineSingle oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only | Drug | I |
Primary outcome
Whole blood and plasma concentrations of total radioactivity and parent drug
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
Urine and faecal recovery of total radioactivity
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
Characterisation and identification of metabolites in plasma, urine and faeces
Time frame: 168-216 h after dosing, depending on the radioactivity recovery
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 22616812Lucero ML, Gonzalo A, Mumford R, Betanzos M, Alejandro A. An overview of bilastine metabolism during preclinical investigations. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:18-24. doi: 10.3109/01480545.2012.682651.
- Background: PubMed 22616810Lucero ML, Patterson AB. Whole-body tissue distribution of total radioactivity in rats after oral administration of [(1)(4)C]-bilastine. Drug Chem Toxicol. 2012 Jun;35 Suppl 1:1-7. doi: 10.3109/01480545.2012.682650.
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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.
Stuart J Mair, MD principal investigator
Syneos Health
Lindsay McGregor study director
Syneos Health
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 [14C]-bilastine in people with Healthy, run by Faes Farma, S.A. at 1 site in United Kingdom.
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 10 inclusion and 14 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 United Kingdom. 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?
Whole blood and plasma concentrations of total radioactivity and parent drug (time frame: 168-216 h after dosing, depending on the radioactivity recovery). The study lists 3 primary outcomes in all. 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 NCT00572611, which also lists 2 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.