Healthy adults will be enrolled into this open-label, Phase 1 research study.Participants will spend about 9 nights and 10 days in the clinical research unit (CRU)and the total time in the study will be about 11 weeks.The goal of this clinical trial is to compare how much of the study drug ibuzatrelvir isin participants' blood after taking one of the two different types of tablets containingthe same amount of ibuzatrelvir without food. The study will also measure how muchibuzatrelvir is in participants' blood after taking one type of the tablets dispersed inwater and when one type of the tablets is taken with food. This study drug is taken bymouth.
This is a Phase 1, open-label, randomized, 4-period, 6-sequence crossover study in
healthy adult participants. The goal of this clinical study is to compare how much of the
oral (taken by mouth) study drug ibuzatrelvir is in participants' blood after taking one
of the two different types of tablets containing the same amount of ibuzatrelvir without
food (fasted). The study will also measure how much ibuzatrelvir is in participants'
blood after taking one type of the tablets dispersed in water and when one type of the
tablets is taken with food. Safety and tolerability after taking the study medication
will also be assessed.
Healthy adult participants will be screened within 28 days prior to the first day of
study treatment. Participants will take one dose of study drug on the first day of each
of 4 dosing periods that are 2-3 days each. Participants will remain in the clinical
research unit (CRU) from Day -1 of Period 1 until completion of procedures on Day 3 of
Period 4. This means that participants will stay in the CRU for a total of 9 nights and
10 days. The follow-up phone call will take place approximately 28-35 days after the last
dose of study drug. The total time in the study is about 10-11 weeks.
The study treatments are:
Treatment A: ibuzatrelvir (original) fasted Treatment B: ibuzatrelvir (new) fasted
Treatment C: ibuzatrelvir (new as dispersion in water) fasted Treatment D: ibuzatrelvir
(new) fed
This is a crossover study which means that the treatment groups will receive the same
treatments (A, B, C, and D) in a different order during the 4 dosing periods.
Group Period 1 Period 2 Period 3 Period 4
1. A (fasted) B (fasted) C (fasted) D (Fed)
2. A (fasted) C (fasted) B (fasted) D (Fed)
3. B (fasted) A (fasted) C (fasted) D (Fed)
4. B (fasted) C (fasted) A (fasted) D (Fed)
5. C (fasted) A (fasted) B (fasted) D (Fed)
6. C (fasted) B (fasted) A (fasted) D (Fed)
During the screening and time in the CRU participants will have:
- Blood and urine samples collected for safety lab tests
- Pharmacokinetics (PK) blood samples collected to detect concentrations of
ibuzatrelvir (up to 40 samples)
- Up to 8 electrocardiograms (ECGs - records the electrical signals controlling your
heart)
- To fast (not eat) for at least 10 hours overnight before 3 of the 4 doses
Approximately 18 participants will be enrolled in the study.
Drug: Ibuzatrelvir co-process API film coated tablet
original
Drug: Ibuzatrelvir filmcoated tablet
new
Inclusion criteria:
1. 18 years of age or older (or the minimum age of consent in accordance with local
regulations) at screening who are overtly healthy as determined by medical
evaluation including medical history, physical examination, laboratory tests, and
ECGs.
2. BMI of 16-32 kg/m2; and a total body weight >45 kg.
3. Participants who are capable of giving signed informed consent and willing and able
to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle
considerations, and other study procedures.
Exclusion Criteria
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy,
cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for
HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
2. Any medical or psychiatric condition including any active suicidal ideation in the
past year or suicidal behavior in the past 5 years or laboratory abnormality or
other conditions that may increase the risk of study participation or, in the
investigator's judgment, make the participant inappropriate for the study.
3. Use of prescription or nonprescription drugs and dietary and herbal supplements
within 14 days or 5 half-lives (whichever is longer) prior to the first dose of
study intervention with the exception of moderate or strong CYP3A inducers which are
prohibited within 14 days plus 5 half-lives prior to the first dose of study
intervention.
4. Previous administration of an investigational product (drug or vaccine) within 30
days or 5 half-lives preceding the first dose of study intervention used in this
study (whichever is longer).
5. Participation in studies of other investigational products (drug or vaccine) at any
time during participation in this study.
6. A positive urine drug test. A single repeat for positive drug screen may be allowed.
7. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants
<60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5
minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or
diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3
BP values should be used to determine the participant's eligibility.
8. An eGFR <60 mL/min/1.73 m² as determined by the CKD-EPI equation using Screat.
9. Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results (including, but not
limited to, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate age
myocardial infarction, ST segment and/or T wave changes suggestive of myocardial
ischemia, second or third degree AV block, or serious bradyarrhythmias or
tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be
repeated twice and the average of the 3 QTcF or QRS values used to determine the
participant's eligibility. Computer interpreted ECGs with abnormal findings should
be overread by an investigator experienced in reading ECGs before excluding a
participant.
10. Participants with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat test, if deemed necessary:
• ALT, AST, T Bili >1.5× ULN.
11. History of alcohol abuse or repeated binge drinking and/or any other illicit drug
use or dependence within 6 months of screening. Binge drinking is defined as a
pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a
general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces
(240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
12. Investigator site staff directly involved in the conduct of the study and their
family members, site staff otherwise supervised by the investigator, and sponsor and
sponsor delegate employees directly involved in the conduct of the study and their
family members.
13. Use of tobacco/nicotine containing products in excess of the equivalent of 5
cigarettes/day or 2 chews of tobacco/day.
14. History of sensitivity reactions to ibuzatrelvir or any of the formulation
components of ibuzatrelvir.
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer