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Caffeine

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 18, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04655040Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy ParticipantsPHASE1 COMPLETED 12 — — Dec 18, 2020Mar 5, 2021Mar 18, 20211 United States
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine
Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48
Secondary Endpoints
Incidence of treatment-emergent adverse events
Baseline through Day 28
Incidence of clinically significant abnormalities in vital signs
Baseline through Day 11
Incidence of clinically significant abnormalities in clinical laboratory values
Baseline through Day 11
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Caffeine and RitlecitinibEXPERIMENTALIn Period 1 Day 1, participants will be dosed with a single oral administration of caffeine 100 milligram (mg) tablet. In Period 2 Day 1 to Day 7, participants will be dosed with a single oral administration of ritlecitinib 200 milligram (mg) tablet. On Day 8, participants will be dosed with caffeine 100 milligram (mg) tablet within 5 minutes after administration of a 200 milligram (mg) dose of ritlecitinib on the morning of Day 8. Dosing with oral 200 milligram (mg) ritlecitinib QD will continue until Day 9.
Interventions
NameTypeDescription
CaffeineDRUG100milligram (mg) tablet taken orally in period 1 and period 2
RitlecitinibOTHER200 milligrams (mg) taken orally once a day(QD) for 8 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: -Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. -BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). - * Male and female participants who are healthy as determined by medical evaluation including medical ...

Countries:United States
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