Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population

NCT03633760 | Unknown Phase 1

• 1 other identifier: INCN/12/Bil-PK/004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (17)

• Pharmacokinetic (Cmax)

  observed maximum plasma concentration

  day1, day4 to day9

• Pharmacokinetic (tmax)

  time to reach Cmax

  day1, day4 to day9

• Pharmacokinetic (λz)

  terminal rate constant

  day1, day4 to day9

• Pharmacokinetic (t½)

  terminal half-life

  day1, day4 to day9

• Pharmacokinetic [AUC(0-24)]

  area under the plasma concentration-time curve from zero to 24 hours after study drug administration

  day1

• Pharmacokinetic [AUC(0-last)]

  from time zero to the time of last quantifiable concentration

  day1

• Pharmacokinetic [AUC(0-inf)]

  from time zero extrapolated to infinity

  day1

• Pharmacokinetic (CL/F)

  apparent systemic clearance following oral dosing

  day1, day4 to day9

• Pharmacokinetic (Vz/F)

  apparent volume of distribution during terminal phase following oral dosing

  day1, day4 to day9

• Pharmacokinetic [AUC(0-inf)/D]

  dose-normalized AUC(0-inf)

  day1

• Pharmacokinetic (Cmax/D)

  dose-normalized Cmax

  day1

• Pharmacokinetic (Cavg)

  average concentration over the study drug interval

  day4 to day9

• Pharmacokinetic [AUC(0-tau)]

  area under the plasma concentration-time curve during the dosing interval following multiple dosing

  day4 to day9

• Pharmacokinetic (FI)

  fluctuation index

  day4 to day9

• Pharmacokinetic (LI)

  linearity index

  day4 to day9

• Pharmacokinetic [RAUC(0-tau)]

  accumulation ratio for AUC(0-tau)

  day4 to day9

• Pharmacokinetic (RCmax)

  accumulation for Cmax

  day4 to day9

Secondary Outcomes (1)

• Adverse events

  day1 to day16

Study Arms (2)

Bilastine 40mg single dose

EXPERIMENTAL

12 eligible subjects will be allocated to this arm and receive a single dose of 40 mg of bilastine

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

Drug: Bilastine 20mg single-dose followed by multiple-dose

Interventions

Bilastine 40mg single dose DRUG

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 40mg single dose

Bilastine 20mg single-dose followed by multiple-dose DRUG

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.

Bilastine 20mg multiple dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• A.Menarini Asia-Pacific Holdings Pte Ltd: lead

Study Sites (1)

Phase I Clinical Trial Centre, Chinese University of Hong Kong

Hong Kong, Hong Kong, 999077, China

RECRUITING

MeSH Terms

Interventions

bilastine

Study Officials

• Andrea Luk, Professor

  Phase I Clinical Trial Centre, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Carolina De Quiroz, MD

CONTACT

+65 6494 7226; carolina.dequiroz@menariniapac.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 16, 2018
• Study Start: August 28, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 31, 2019
• Last Updated: January 10, 2019

Record last verified: 2018-08

Locations

CN (1)