| Eligibility |
Inclusion Criteria:
1. Male or female non-smokers (no use of tobacco or nicotine products within 3 months
prior to screening), =18 and =55 years of age, with body-mass-index (BMI) >18 and
<29.9 kilogram per meter square (kg/m^2) and body weight =50.0 kg to =100.0 kg for
males and =40.0 kg to =90.0 kg for females.
2. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to
inclusion on Day 1.
2. the absence of clinically significant history of neurological, endocrine,
cardiovascular, respiratory, hematological, immunological, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease.
3. Standard 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine
position in the following ranges:120 milliseconds (ms)<PR<220 ms, QRS<120 ms, QTcF=450
ms if male, =470 ms if female and normal ECG tracing unless the Investigator considers
an ECG tracing abnormality to be not clinically relevant.
4. Female participants of non-childbearing potential must be:
1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to inclusion
on Day 1) with confirmation by documented follicle-stimulating hormone (FSH)
levels 30 milli-international units per milliliter (mIU/mL); or
2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy
or tubal ligation) at least 3 months prior to inclusion on Day 1.
5. Female participants of childbearing potential who are sexually active with a
non-sterile male partner (sterile male partners are defined as men vasectomized for at
least 3 months prior to inclusion on Day 1) must be willing to use one of the
following acceptable contraceptive methods throughout the study and for 30 days after
the last dose:
1. simultaneous use of hormonal contraceptive (e.g., oral, patch, depot injection,
implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device
used for at least 4 weeks prior to inclusion on Day 1 (must agree to use the same
contraceptive throughout the study) and condom for the male partner;
2. simultaneous use of non-hormonal intrauterine device placed at least 4 weeks
prior to inclusion on Day 1 and condom for the male partner;
3. simultaneous use of diaphragm or cervical cap with spermicide and condom for the
male partner, started at least 21 days prior to inclusion on Day 1.
6. Male participants who are not vasectomized for at least 3 months prior to inclusion on
Day 1 and who are sexually active with a female partner of childbearing potential must
be willing to use one of the following acceptable contraceptive methods from the first
dose and for 90 days after the last dose:
1. simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot
injection, implant, vaginal ring, intrauterine device) or non-hormonal
intrauterine device used for at least 4 weeks prior to sexual intercourse for the
female partner;
2. simultaneous use of condom and a diaphragm or cervical cap with spermicide for
the female partner.
7. Male participants (including men who have had a vasectomy) with a pregnant partner
must agree to use a condom from the first dose and for 90 days after the last dose.
8. Male participants must be willing not to donate sperm for 90 days after the last dose.
9. Willing to take off dentures or mouth piercing at the time of dosing.
10. Able to understand the study procedures and provide signed informed consent to
participate in the study.
Exclusion Criteria:
1. Any clinically significant abnormal finding at physical examination at screening.
2. Clinically significant abnormal laboratory test results or positive serology test
results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or
human immunodeficiency virus (HIV) antigen and antibody at screening.
3. Frequent history of headaches and/or migraine more than twice a month, recurrent
nausea and/or vomiting (for vomiting only: more than twice a month).
4. Positive pregnancy test or lactating female participant.
5. Positive urine drug screen, urine cotinine test, or alcohol breath test.
6. Known allergic reactions to fexofenadine HCl or other related drugs, or to any
excipient in the formulation.
7. Presence or history of drug hypersensitivity, or allergic disease diagnosed and
treated by a physician.
8. Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood
pressure lower than 95 or over 140 mmHg, diastolic blood pressure lower than 45 or
over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
9. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or
asymptomatic postural hypotension defined as a decrease of =20 mmHg in systolic blood
pressure, decrease of =10 mmHg in diastolic blood pressure, and increase of =30 bpm in
heart rate within 3 minutes when changing from supine to standing position.
10. History of drug abuse within 1 year prior to screening or recreational use of soft
drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine
[PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within
3 months prior to screening.
11. History of alcohol abuse within 1 year prior to screening or regular use of alcohol
within 6 months prior to screening that exceeds 10 units for women or 15 units for men
of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of
distilled alcohol 40%).
12. Use of medications for the timeframes specified below, with the exception of hormonal
contraceptives and medications exempted by the Investigator on a case-by-case basis
because they are judged unlikely to affect the pharmacokinetic (PK) profile of the
study drug or participant safety (e.g., topical drug products without significant
systemic absorption):
1. any biologics (antibody or its derivatives) given within 4 months prior to
inclusion on Day 1;
2. depot injection or implant within 3 months prior to inclusion on Day 1;
3. any drug known to induce or inhibit cytochrome P450 (CYP)3A4 metabolism,
including St. John's wort, within 30 days prior to inclusion on Day 1;
4. prescription medications within 14 days prior to inclusion on Day 1;
5. any vaccine, including COVID-19 vaccine, within 28 days prior to inclusion on Day
1;
6. over-the-counter (OTC) medications and natural health products (including herbal
remedies such as homeopathic and traditional medicines, probiotics, food
supplements such as vitamins, minerals, amino acids, essential fatty acids, and
protein supplements used in sports) within 7 days prior to inclusion on Day 1,
with the exception of the occasional use of acetaminophen (up to 2 g daily);
7. any drug known to be P-glycoproteins (Pg-p) inhibitors or inducers, Organic anion
transporting polypeptides (OATP) inhibitors or inducers or any medication
containing ketoconazole (e.g., Nizoral), itraconazole, verapamil, erythromycin,
rifampin, and carbamazepine within 14 days prior to inclusion on Day 1 and during
the study period.
8. any antacids containing aluminum and magnesium within 14 days prior to inclusion
on Day 1 and during the study period.
9. any antihistaminic drug within 14 days prior to inclusion on Day 1.
10. any tricyclic antidepressants within 14 days prior to inclusion on Day 1.
13. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to inclusion on Day 1,
administration of a biological product in the context of a clinical research study
within 90 days prior to inclusion on Day 1, or concomitant participation in an
investigational study involving no drug or device administration.
14. Excessive consumption of beverages containing xanthine bases (more than 4 cups or
glasses per day).
15. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of
blood within 30 days, or more than 499 mL within 56 days prior to the first inclusion
on Day 1.
16. Presence of orthodontic braces or orthodontic retention wires or dentures, or any
physical findings in the mouth or tongue that would be likely to interfere with
successful completion of the dosing procedure.
17. Presents difficulty with venipuncture and/or poor venous access.
18. Any reason which, in the opinion of the Investigator, would prevent the participant
from participating in the study.
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