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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05525910
Other study ID # C4671023
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 31, 2022
Est. completion date November 7, 2022

Study information

Verified date December 2022
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 7, 2022
Est. primary completion date November 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nirmatrelvir/ ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ ritonavir
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition

Locations

Country Name City State
United States New Haven Clinical Research Unit New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under curve from time zero to 72 hours post dose 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours
Primary Peak plasma concentration (Cmax) 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours
Secondary Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Baseline (Day 0) up to 28 days after last dose of study medication
Secondary Number of Participants With Notable Electrocardiogram (ECG) Values Baseline (Day 0) up to day 4 of treatment period 4
Secondary Number of Participants With Clinically Notable Vital Signs Baseline (Day 0) up to day 4 of treatment period 4
Secondary Number of Participants With Clinically Notable Changes in Clinical laboratory Baseline (Day 0) up to day 4 of treatment period 4
Secondary Number of Participants With Clinically Notable Abnormality in physical examination Baseline (Day 0) up to day 4 of treatment period 4
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