Status:
COMPLETED
STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.
Detailed Description
Combined 5-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Supra-therapeutic Exposur...
Eligibility Criteria
Inclusion
- Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs)
- Japanese subjects who have four Japanese biologic grandparents born in Japan
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
- Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
- Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
- Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04756531
Start Date
February 11 2021
End Date
September 1 2021
Last Update
October 15 2024
Active Locations (2)
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1
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
2
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070