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A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers

NCT03647670 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-23

No results posted yet for this study

Summary

This is a Phase 1, randomized, 2-way crossover, multiple dose, open label study of the effect of PF-04965842 on midazolam PK in healthy subjects. The study will demonstrate the effect of multiple dose PF-04965842 on the pharmacokinetics of a single, oral dose of midazolam in healthy subjects.

Conditions

  • Phase 1

Interventions

DRUG

PF-04965842

orally bioavailable small molecule that selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site.

DRUG

Midazolam

substrate which undergoes extensive metabolism by CYP3A4 and CYP3A5 and acts as a sensitive probe for evaluating drug interaction with respect to these isoenzymes

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · 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
2018-07-03
Primary Completion
2018-10-16
Completion
2018-10-16
FDA Drug
Yes

Countries

  • Belgium

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 NCT03647670 on ClinicalTrials.gov