PharmacokineticsPhase 1NCT03633760
Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population
A Phase 1 study testing Bilastine 40mg single dose and Bilastine 20mg single-dose followed by multiple-dose in people with Pharmacokinetics, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in China.
Trial summary
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study which will be conducted in Phase I Clinical Trial Centre, Chinese University of Hong Kong, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Bilastine 40mg single dose and Bilastine 20mg single-dose followed by multiple-dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2018to 31 Jul 2019
- 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
- Ethnic Chinese males and females between 18 and 45 years of age (inclusive).
- Having voluntarily given their informed consent to participate in the study after receiving information about the design, aims and potential risks that could result from the study and being informed that they could refuse to take part in or withdraw from the study at any time.
- Body mass of no less than 50 kg. Body mass index: 19 to 24 kg/m2 (inclusive).
- No clinically significant abnormal findings from the physical examination, vital signs check, electrocardiogram (ECG), medical history, or clinical laboratory results during screening and pre-dosing of Day 1.
- A negative screen for HIV and hepatitis B.
- A negative urine or breathalyzer screen for alcohol and negative urine screen for drugs of abuse.
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- Are non-tobacco / nicotine users (within 3 months prior to screening visit).
- A negative serum pregnancy test for female subjects.
- Subjects who are willing to comply with the contraception restrictions for this study:
- True abstinence.
- Barrier methods with spermicidal use. The use of barrier contraceptives should always be supplemented with the use of a spermicide, where available.
- Intrauterine devices: intrauterine device with the use of condom or spermicide.
- Sterilization of male subjects (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, haematological, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, jeopardises the safety of the subject or will impact the validity of the study results.
- History of allergic or adverse response to antihistamine drugs.
- Participated in a clinical trial within 90 days prior to screening.
- Donated blood within 90 days prior to screening.
- Donated plasma within 90 days prior to screening.
- Abnormal diet or substantial changes in eating habits within 30 days prior to screening.
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- Used any prescription medication within 14 days prior to or during screening, especially any known P-glycoprotein transporter inhibitors agents (ketoconazole, erythromycin, ciclosporin, digoxin, etc.).
- Used any prescription or any over-the-counter medication, herbal or traditional Chinese medication within 7 days prior to or during screening.
- Intake of grapefruit or any other citrus fruit, fruit juice or cranberries within 72 hours prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Phase I Clinical Trial Centre, Chinese University of Hong Kong
Hong Kong, Hong Kong, 999077
Andrea Luk, Professor
About this study
Official title: A Different Level of Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of Bilastine in a Chinese Population
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study which will be conducted in Phase I Clinical Trial Centre, Chinese University of Hong Kong, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects.
Read the detailed description
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects. Total 24 subjects will be enrolled into the study and divided into 2 cohorts, 12 subjects in each cohort.
Single-dose only cohort treatment duration is 1 day and receive a single dose of 40 mg of bilastine then collect PK blood sample. Single-dose followed by multiple-dose cohort treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine 20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to Day 9 and collect PK blood samples. The primary objective of the study is to determine the PK properties of orally administered bilastine in healthy Chinese population. The secondary objective of the study is to evaluate the safety and tolerability of bilastine administered as a single and multiple doses in healthy Chinese subjects.
- Conditions
- Pharmacokinetics
- Being tested
- Bilastine 40mg single dose, Bilastine 20mg single-dose followed by multiple-dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilastine 40mg single doseDrug
Single-dose only cohort treatment duration is 1 day. After the screening period, eligible subjects will be allocated to receive a single dose of 40 mg of bilastine
Bilastine 20mg single-dose followed by multiple-doseDrug
Single-dose followed by multiple-dose cohort treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine 20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to Day 9.
| Study group | Role | What they receive |
|---|---|---|
| Bilastine 40mg single dose | Experimental | 12 eligible subjects will be allocated to this arm and receive a single dose of 40 mg of bilastine Receives: Drug: Bilastine 40mg single dose |
| Bilastine 20mg multiple dose | Experimental | 12 eligible subjects will be allocated to this arm and receive a single dose of bilastine 20 mg on Day 1 and six doses of bilastine 20 mg from Day 4 to Day 9 Receives: Drug: Bilastine 20mg single-dose followed by multiple-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (Cmax)
observed maximum plasma concentration
Measured: day1, day4 to day9
Pharmacokinetic (tmax)
time to reach Cmax
Measured: day1, day4 to day9
Pharmacokinetic (λz)
terminal rate constant
Measured: day1, day4 to day9
Pharmacokinetic (t½)
terminal half-life
Measured: day1, day4 to day9
Pharmacokinetic [AUC(0-24)]
area under the plasma concentration-time curve from zero to 24 hours after study drug administration
Measured: day1
Pharmacokinetic [AUC(0-last)]
from time zero to the time of last quantifiable concentration
Measured: day1
Pharmacokinetic [AUC(0-inf)]
from time zero extrapolated to infinity
Measured: day1
Pharmacokinetic (CL/F)
apparent systemic clearance following oral dosing
Measured: day1, day4 to day9
Pharmacokinetic (Vz/F)
apparent volume of distribution during terminal phase following oral dosing
Measured: day1, day4 to day9
Pharmacokinetic [AUC(0-inf)/D]
dose-normalized AUC(0-inf)
Measured: day1
Pharmacokinetic (Cmax/D)
dose-normalized Cmax
Measured: day1
Pharmacokinetic (Cavg)
average concentration over the study drug interval
Measured: day4 to day9
Pharmacokinetic [AUC(0-tau)]
area under the plasma concentration-time curve during the dosing interval following multiple dosing
Measured: day4 to day9
Pharmacokinetic (FI)
fluctuation index
Measured: day4 to day9
Pharmacokinetic (LI)
linearity index
Measured: day4 to day9
Pharmacokinetic [RAUC(0-tau)]
accumulation ratio for AUC(0-tau)
Measured: day4 to day9
Pharmacokinetic (RCmax)
accumulation for Cmax
Measured: day4 to day9
Secondary outcomes (1)
Adverse events
Safety will be evaluated with summary of Adverse Events
Measured: day1 to day16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start28 Aug 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.Menarini Asia-Pacific Holdings Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Luk, Professor, Principal investigator, Phase I Clinical Trial Centre, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633760
- Sponsor's protocol ID
- INCN/12/Bil-PK/004
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Different Level of Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of Bilastine in a Chinese Population
- ClinicalTrials.gov ID
- NCT03633760
- Acronym / sponsor ID
- INCN/12/Bil-PK/004
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- A.Menarini Asia-Pacific Holdings Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 16 Aug 2018 (actual)
- 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.
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study which will be conducted in Phase I Clinical Trial Centre, Chinese University of Hong Kong, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects.
Detailed description
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects. Total 24 subjects will be enrolled into the study and divided into 2 cohorts, 12 subjects in each cohort.
Single-dose only cohort treatment duration is 1 day and receive a single dose of 40 mg of bilastine then collect PK blood sample. Single-dose followed by multiple-dose cohort treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine 20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to Day 9 and collect PK blood samples. The primary objective of the study is to determine the PK properties of orally administered bilastine in healthy Chinese population. The secondary objective of the study is to evaluate the safety and tolerability of bilastine administered as a single and multiple doses in healthy Chinese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilastine 40mg single dose | Experimental | Drug: Bilastine 40mg single dose12 eligible subjects will be allocated to this arm and receive a single dose of 40 mg of bilastine |
| Bilastine 20mg multiple dose | Experimental | Drug: Bilastine 20mg single-dose followed by multiple-dose12 eligible subjects will be allocated to this arm and receive a single dose of bilastine 20 mg on Day 1 and six doses of bilastine 20 mg from Day 4 to Day 9 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Ethnic Chinese males and females between 18 and 45 years of age (inclusive).
- Having voluntarily given their informed consent to participate in the study after receiving information about the design, aims and potential risks that could result from the study and being informed that they could refuse to take part in or withdraw from the study at any time.
- Body mass of no less than 50 kg. Body mass index: 19 to 24 kg/m2 (inclusive).
- No clinically significant abnormal findings from the physical examination, vital signs check, electrocardiogram (ECG), medical history, or clinical laboratory results during screening and pre-dosing of Day 1.
- A negative screen for HIV and hepatitis B.
Key exclusion criteria (9 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, haematological, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, jeopardises the safety of the subject or will impact the validity of the study results.
- History of allergic or adverse response to antihistamine drugs.
- Participated in a clinical trial within 90 days prior to screening.
- Donated blood within 90 days prior to screening.
- Donated plasma within 90 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 |
|---|---|---|
| Bilastine 40mg single doseSingle-dose only cohort treatment duration is 1 day. After the screening period, eligible subjects will be allocated to receive a single dose of 40 mg of bilastine | Drug | Bilastine 40mg single dose |
| Bilastine 20mg single-dose followed by multiple-doseSingle-dose followed by multiple-dose cohort treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine 20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to Day 9. | Drug | Bilastine 20mg multiple dose |
Primary outcome
Pharmacokinetic (Cmax)
Time frame: day1, day4 to day9
observed maximum plasma concentration
Pharmacokinetic (tmax)
Time frame: day1, day4 to day9
time to reach Cmax
Pharmacokinetic (λz)
Time frame: day1, day4 to day9
terminal rate constant
Pharmacokinetic (t½)
Time frame: day1, day4 to day9
terminal half-life
Pharmacokinetic [AUC(0-24)]
Time frame: day1
area under the plasma concentration-time curve from zero to 24 hours after study drug administration
Pharmacokinetic [AUC(0-last)]
Time frame: day1
from time zero to the time of last quantifiable concentration
Pharmacokinetic [AUC(0-inf)]
Time frame: day1
from time zero extrapolated to infinity
Pharmacokinetic (CL/F)
Time frame: day1, day4 to day9
apparent systemic clearance following oral dosing
Pharmacokinetic (Vz/F)
Time frame: day1, day4 to day9
apparent volume of distribution during terminal phase following oral dosing
Pharmacokinetic [AUC(0-inf)/D]
Time frame: day1
dose-normalized AUC(0-inf)
Pharmacokinetic (Cmax/D)
Time frame: day1
dose-normalized Cmax
Pharmacokinetic (Cavg)
Time frame: day4 to day9
average concentration over the study drug interval
Pharmacokinetic [AUC(0-tau)]
Time frame: day4 to day9
area under the plasma concentration-time curve during the dosing interval following multiple dosing
Pharmacokinetic (FI)
Time frame: day4 to day9
fluctuation index
Pharmacokinetic (LI)
Time frame: day4 to day9
linearity index
Pharmacokinetic [RAUC(0-tau)]
Time frame: day4 to day9
accumulation ratio for AUC(0-tau)
Pharmacokinetic (RCmax)
Time frame: day4 to day9
accumulation for Cmax
1 secondary outcome
Adverse events
Time frame: day1 to day16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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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.
Andrea Luk, Professor principal investigator
Phase I Clinical Trial Centre, Chinese University of Hong Kong
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 40mg single dose and Bilastine 20mg single-dose followed by multiple-dose in people with Pharmacokinetics, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in China.
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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Jan 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Carolina De Quiroz, MD (+65 6494 7226, carolina.dequiroz@menariniapac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (Cmax) (time frame: day1, day4 to day9). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2019.