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Nirmatrelvir/ritonavir

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05898672A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine RosuvastatinPHASE1 COMPLETED 12 — — Jun 9, 2023Aug 10, 2023Oct 28, 20241 Belgium
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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 — 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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