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Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

NCT04065633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-07

No results posted yet for this study

Summary

Part A

* To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
* To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
* To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation

Part B

• To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions

Parts A \& B

* To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize \[break down\] certain medications)

o Genotyping is the collection of a small sample of blood that contains your genes
* To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
* To measure the amount of study drug in the blood after single doses of the different formulations
* To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

P3-Fast

200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions

DRUG

Comm-Fast

200 mg PF-04965842 commercial tablet formulation under fasted conditions

DRUG

Vari-Fast

200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions

DRUG

Comm-Fed

200 mg PF-04965842 commercial tablet formulation under fed conditions

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

  • Sylvester Pawlak, APRN · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2019-12-14
Completion
2019-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04065633 on ClinicalTrials.gov