A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants

Launched by PFIZER · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two new combination tablets of nirmatrelvir and ritonavir with the already available Paxlovid tablet to see how similar they are in terms of how the body absorbs the medication. The study will include healthy adults aged 18 and older who weigh more than 50 kilograms and have a Body Mass Index (BMI) between 16 and 32. Participants must be in good health, confirmed through medical exams and tests, and not have any significant health issues.

If you join this study, you will take one of the study medicines by mouth after fasting (not eating) overnight. The trial involves four different treatments that you'll receive during your stay at a clinical research unit. After taking the medication, blood samples will be collected to monitor how your body processes it. You'll stay in the unit for a short time and will have a follow-up call about a month later to check on your health. This research aims to ensure that the new tablets are safe and effective for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG (electrocardiogram).
• • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• • Female participants of childbearing potential must have a negative pregnancy test at screening and on Day -1.
• • BMI (Body Mass Index) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).
• • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD (Informed consent Document) and in this protocol.
• 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).
• • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• • History of HIV (Human Immunodeficiency Virus) infection, Hepatitis B, or Hepatitis C; positive testing for HIV, HBsAg (Hepatitis B surface Antigen), HBcAb (Hepatitis B core Antibody) or HCVAb (Hepatitis C Virus Antibody). Hepatitis B vaccination is allowed.
• • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior 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.
• • 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.
• • Participants 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.