A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05898672

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the effect of the study medicine (called nirmatrelvir/ritonavir) on the pharmacokinetics of the medicine rosuvastatin in healthy volunteers. Pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it.

This study is seeking participants who:

are male and female participants who are overtly healthy
are 18 years of age or older
have a Body mass Index (BMI) of 16-32 kg/m2 and total body weight >50 kg (110 lb).

All participants in this study will receive nirmatrelvir/ritonavir, a standard treatment for mild-to-moderate COVID-19. All participants will also receive rosuvastatin.

Nirmatrelvir/ritonavir will be given by mouth at the study clinic 2 times a day. Rosuvastatin will be given by mouth at the study clinic once (as a single dose).

We will compare participant experiences to help us determine the effect of nirmatrelvir/ritonavir on the pharmacokinetics of rosuvastatin.

Participants will take part in this study for approximately 11 weeks. During this time, they will have 10 days at the study clinic and 1 follow-up phone call. Blood samples will be collected during participants' time at the study clinic.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics Healthy Volunteers	Drug: Rosuvastatin Drug: Nirmatrelvir/ritonavir	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A PHASE 1, RANDOMIZED, FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF NIRMATRELVIR (PF-07321332)/RITONAVIR ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

Anticipated Study Start Date :

Jun 14, 2023

Anticipated Primary Completion Date :

Aug 14, 2023

Anticipated Study Completion Date :

Aug 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A: rosuvastatin Rosuvastatin tablets	Drug: Rosuvastatin Single oral dose of rosuvastatin tablets
Experimental: Treatment B: rosuvastatin + nirmatrelvir/ritonavir Rosuvastatin + nirmatrelvir/ritonavir tablets	Drug: Rosuvastatin Single oral dose of rosuvastatin tablets Drug: Nirmatrelvir/ritonavir Twice daily oral doses of nirmatrelvir/ritonavir tablets

Arm

Intervention/Treatment

Active Comparator: Treatment A: rosuvastatin

Rosuvastatin tablets

Drug: Rosuvastatin

Single oral dose of rosuvastatin tablets

Experimental: Treatment B: rosuvastatin + nirmatrelvir/ritonavir

Rosuvastatin + nirmatrelvir/ritonavir tablets

Drug: Rosuvastatin

Single oral dose of rosuvastatin tablets

Drug: Nirmatrelvir/ritonavir

Twice daily oral doses of nirmatrelvir/ritonavir tablets

Outcome Measures

Primary Outcome Measures

Rosuvastatin area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Rosuvastatin maximum plasma concentration (Cmax) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]

Secondary Outcome Measures

Rosuvastatin area under the concentration-time curve from time zero to time of last quantifiable concentration (AUClast) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Rosuvastatin time of maximum plasma concentration (Tmax) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Rosuvastatin half-life (t1/2) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Rosuvastatin apparent clearance (CL/F) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Rosuvastatin apparent volume of distribution (Vz/F) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours]
Number of participants with treatment emergent treatment-related adverse events (AEs) [Baseline (Day 0) up to 28 days after the last dose of study medication]
Number of participants with clinically notable vital signs [Baseline (Day 0) up to 28 days after the last dose of study medication]
Number of participants with clinically notable changes in clinical laboratory [Baseline (Day 0) up to 28 days after the last dose of study medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
BMI of 16-32 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 on 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 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, HBsAg, or 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.
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.