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

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

PF-06865571 administered Day 7-14 · 1 trial · 1 indication

Phase 1 1
NCT03534648Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult SubjectsHealthy
COMPLETED16 Analytics
PHASE1COMPLETED
Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
HealthyUnlock trial analytics

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 to 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

Frequently asked questions about PF-06865571 administered Day 7-14

What is PF-06865571 used for?

PF-06865571 is an investigational small molecule being studied in healthy adult subjects. It is being evaluated in a Phase 1 clinical trial to assess its pharmacokinetic drug-drug interaction with another Pfizer compound, PF-05221304. The drug is not approved and remains in clinical development.

Who makes PF-06865571?

PF-06865571 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting a Phase 1 clinical trial to evaluate the drug's pharmacokinetic interactions in healthy volunteers.

What phase is PF-06865571 in?

PF-06865571 is in Phase 1 clinical development. It is an investigational drug that has not been approved by regulatory authorities. The single Phase 1 trial studying this drug has been completed, and it remains in early-stage clinical research.

What clinical trials is PF-06865571 in?

PF-06865571 has been studied in one completed Phase 1 clinical trial, identified as NCT03534648. This trial evaluated the pharmacokinetic drug-drug interaction between PF-06865571 and PF-05221304 in healthy adult subjects. The study enrolled 16 participants and was conducted in Belgium.

Is PF-06865571 the same as PF-05221304?

No, PF-06865571 is not the same as PF-05221304. These are two distinct investigational compounds developed by Pfizer. The clinical trial NCT03534648 was designed to evaluate the pharmacokinetic drug-drug interaction between these two separate drugs when administered together in healthy subjects.