How different ibuzatrelvir tablets enter the bloodstream in healthy adults
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 4-PERIOD, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY AND EFFECT OF FOOD FOLLOWING ORAL ADMINISTRATION OF A NEW TABLET FORMULATION RELATIVE TO THE ORIGINAL FORMULATION OF IBUZATRELVIR IN HEALTHY ADULT PARTICIPANTS
This study will see if the original and a new ibuzatrelvir tablet—taken fasted, dispersed in water, or taken with food—change how much medicine gets into the blood of healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région de) |
| Trial ID | NCT07552779 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label, randomized 4-period, 6-sequence crossover study in healthy adults to compare blood levels of ibuzatrelvir after different tablet formulations and dosing conditions. Each participant receives a single dose in each of four periods (original tablet fasted, new tablet fasted, new tablet dispersed in water fasted, and new tablet fed) with short inpatient stays for intensive blood sampling. The study measures pharmacokinetics (how much drug is in the blood over time) and monitors safety and tolerability. Participants stay in the clinic for about 9 nights and 10 days across the dosing periods and complete a follow-up call about 28–35 days after the last dose, with total participation around 10–11 weeks.
Who should consider this trial
Good fit: Healthy adults aged 18 or older who weigh more than 45 kg, have a BMI of 16–32 kg/m2, no significant medical conditions, and can comply with inpatient visits are suitable candidates.
Not a fit: People with active COVID-19, children, pregnant or breastfeeding individuals, or those with significant medical conditions are unlikely to receive direct clinical benefit from participating.
Why it matters
Potential benefit: If successful, the study could identify a formulation and dosing instructions that give predictable blood levels and more convenient ways to take ibuzatrelvir.
How similar studies have performed: Formulation, bioavailability, and food-effect crossover studies are routine in drug development and have often shown meaningful differences in blood levels between formulations or dosing conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brussels, Bruxelles-capitale, Région de
- Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région de, Belgium (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.