Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898672
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2023-06-01
Brief Title:
A Study to Learn About the Study Medicine Called NirmatrelvirRitonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 RANDOMIZED FIXED SEQUENCE MULTIPLE-DOSE OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF NIRMATRELVIR PF-07321332RITONAVIR ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the effect of the study medicine called nirmatrelvirritonavir 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 kgm2 and total body weight 50 kg 110 lb
All participants in this study will receive nirmatrelvirritonavir a standard treatment for mild-to-moderate COVID-19 All participants will also receive rosuvastatin
Nirmatrelvirritonavir 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 nirmatrelvirritonavir 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
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 kgm2 and total body weight 50 kg 110 lb
All participants in this study will receive nirmatrelvirritonavir a standard treatment for mild-to-moderate COVID-19 All participants will also receive rosuvastatin
Nirmatrelvirritonavir 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 nirmatrelvirritonavir 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503570-20-00 | REGISTRY | CTIS EU | None |
| 2023-503570-20 | EUDRACT_NUMBER | None | None |