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

Healthy Participants Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Single Dose, Crossover Study to Estimate the Relative Bioavailability of Nirmatrelvir and Ritonavir Following Oral Administration of 4 Different Fixed Dose Combination Tablet Formulations Relative to The Commercial Tablet Formulation in Healthy Adult Participants Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525910
• Other study ID #: C4671023
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Biological Availability
• Healthy Participants

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

External Links

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