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Nirmatrelvir/ritonavir

Phase 1

Pharmacokinetics | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 28, 2024

Target and mechanism

ModalitySmall molecule

Also known as nirmatrelvir

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Nirmatrelvir/ritonavir · 1 trial · 2 indications

Phase 1 1
NCT05898672A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine RosuvastatinPharmacokinetics
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin
Pharmacokinetics
NCT0589867212
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Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Rosuvastatin in Period 1 and 2
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2
Maximum Observed Concentration (Cmax) of Rosuvastatin in Period 1 and 2
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2

Secondary Endpoints

Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin in Period 1 and 2
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2
Time for Cmax (Tmax) of Rosuvastatin in Period 1 and 2
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2
Terminal Half-Life (t1/2) of Rosuvastatin in Period 1 and 2
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment A: rosuvastatinACTIVE_COMPARATORRosuvastatin tablets
Treatment B: rosuvastatin + nirmatrelvir/ritonavirEXPERIMENTALRosuvastatin + nirmatrelvir/ritonavir tablets

Interventions

NameTypeDescription
RosuvastatinDRUGSingle oral dose of rosuvastatin tablets
Nirmatrelvir/ritonavirDRUGTwice daily oral doses of nirmatrelvir/ritonavir tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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 moni...

Countries:Belgium
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Frequently asked questions about Nirmatrelvir/ritonavir

What is Nirmatrelvir/ritonavir used for?

Nirmatrelvir/ritonavir is an investigational small molecule being studied for COVID-19, hepatic impairment, and bioavailability in healthy participants. It is developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development.

Who makes Nirmatrelvir/ritonavir?

Nirmatrelvir/ritonavir is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is in Phase 1 clinical development for conditions including COVID-19 and hepatic impairment.

What phase is Nirmatrelvir/ritonavir in?

Nirmatrelvir/ritonavir is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing or completed to evaluate its safety and effects.

What clinical trials is Nirmatrelvir/ritonavir in?

Nirmatrelvir/ritonavir has been studied in several Phase 1 trials, including NCT04962022, NCT04962230, NCT05064800, and NCT05441215. These trials assess drug-drug interactions and effects in healthy participants, including lactating women.

Is Nirmatrelvir/ritonavir the same as nirmatrelvir?

Yes, nirmatrelvir/ritonavir is also known as nirmatrelvir. The drug is a combination product that includes nirmatrelvir and ritonavir, and it is being developed by Pfizer, Inc. for COVID-19 and other conditions.