Recent Updates
Recently added Catalysts

PF-06865571 administered Day 7-14

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 18, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03534648Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult SubjectsPHASE1 COMPLETED 16Apr 19, 2018Aug 29, 2018Sep 18, 20181 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Day 7, 0-12 hours and Day 14 0-12 hours

Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.

Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Day 7, 0-12 hours and Day 14 0-12 hours

Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)

Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Day 7, 0-12 hours and Day 14 0-12 hours

Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.

Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Day 7, 0-12 hours and Day 14 0-12 hours

Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)

Secondary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Screening up to 28 days after last dose of study medication
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Effect of PF-05221304 on PF-06865571 PKEXPERIMENTAL -
Effect of PF-06865571 on PF-05221304 PKEXPERIMENTAL -
Interventions
NameTypeDescription
PF-06865571 administered Day 7-14DRUGPF-06865571 administered Q12hr on Days 7-14
PF-06865571 administered Day 1-14DRUGPF-06865571 administered Q12hr on Day 7-14
PF-05221304 administered Day 1-14DRUGPF-05221304 administered Q12hr on Days 1-14
PF-05221304 administered Day 7-14DRUGPF-05221304 administered Q12hr Days 7-14
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: 1. Healthy female subjects of nonchildbearing potential and/or male subjects. 2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Criteria 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonar...

Countries:Belgium
Unlock Eligibility Criteria