Overview

Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants

Status:
Not yet recruiting
Trial end date:
2022-11-07
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to estimate the relative bioavailability of nirmatrelvir/ritonavir of 4 different FDC tablet formulations relative to the commercial tablet formulation under fasted conditions in healthy adult participants.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Treatments:
Ritonavir
Criteria
Inclusion Criteria:

- Participants who are overtly healthy as determined by medical evaluation including
medical history, physical examination (PE), laboratory tests, vital signs and standard
12 lead ECGs.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

- Positive test result for SARS-CoV-2 infection at the time of Screening or Day -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).

- Clinically relevant abnormalities requiring treatment (eg, acute myocardial
infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious
tachy or brady arrhythmias) or indicating serious underlying heart disease (eg,
prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart
Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White
syndrome).

- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface
antibody (HCVAb). Hepatitis B vaccination is allowed.

- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of study
intervention.

- Participant who have received a COVID-19 vaccine within 7 days before screening or
admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the
study confinement period.

- A positive urine drug test.