NCT05898672

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Single oral dose of rosuvastatin tablets
DRUG	Nirmatrelvir/ritonavir	Twice daily oral doses of nirmatrelvir/ritonavir tablets

Timeline

• Start date: 2023-06-09
• Primary completion: 2023-08-10
• Completion: 2023-08-10
• First posted: 2023-06-12
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study