CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Rosuvastatin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05898672
NCT05898672Phase 1Completed

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

Pfizer·interventional·Posted Jun 12, 2023·Updated Oct 28, 2024

In Brief

A Phase 1 clinical trial evaluating Rosuvastatin and Nirmatrelvir/ritonavir for Pharmacokinetics and Healthy Volunteers. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJun 12, 2023
Enrollment StartJun 9, 2023
Primary CompletionAug 10, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.1 years ago

Interventions

Rosuvastatindrug

Single oral dose of rosuvastatin tablets

Nirmatrelvir/ritonavirdrug

Twice daily oral doses of nirmatrelvir/ritonavir tablets