Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants
Study Details
Study Description
Brief Summary
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A Single oral dose of ritonavir at -12 hours prior to PF-07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing. |
Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1
Drug: Ritonavir
Single oral dose of ritonavir 100 mg at -12 hours prior to PF-07321332/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours after PF-07321332/ritonavir dosing.
|
| Experimental: Treatment B Single oral dose of ritonavir at -12 hours prior to PF 07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing. |
Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1
Drug: Ritonavir
Single oral dose of ritonavir 100 mg at -12 hours prior to PF-07321332/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours after PF-07321332/ritonavir dosing.
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
Secondary Outcome Measures
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Plasma Decay Half-Life (t1/2) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Apparent Oral Clearance (CL/F) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Apparent Volume of Distribution (Vz/F) of PF-07321332 [Day 1 pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hour post-dose]
- Number of Participants With Laboratory Abnormalities [Baseline to Day 3]
- Number of participants with Treatment-Emergent Adverse Events (TEAEs) [Baseline up to Day 3]
- Number of Participants With Clinically Significant Change From Baseline in Vital Sign [Day 1 to Day 3]
- Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings [Day 1 ot Day 3]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. Female participants of childbearing potential must have a negative pregnancy test.
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Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria:
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Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of Screening or Day -1.
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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).
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Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy- or brady brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure, underlying structural heart disease, Wolff Parkinson-White syndrome).
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Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
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History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
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Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg,. contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Haven Clinical Research Unit | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4671019