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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05898672
• Other study ID #: C4671052
• Secondary ID: 2023-503570-2020
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• Rosuvastatin
Single oral dose of rosuvastatin tablets
• Nirmatrelvir/ritonavir
Twice daily oral doses of nirmatrelvir/ritonavir tablets

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Rosuvastatin half-life (t1/2)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Secondary	Rosuvastatin apparent clearance (CL/F)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours
Secondary	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
Secondary	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
Secondary	Number of participants with clinically notable vital signs		Baseline (Day 0) up to 28 days after the last dose of study medication
Secondary	Number of participants with clinically notable changes in clinical laboratory		Baseline (Day 0) up to 28 days after the last dose of study medication

External Links

•   To obtain contact information for a study center near you, click here.