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A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions

NCT02201511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-11-10

No results posted yet for this study

Summary

The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.

Conditions

  • Healthy

Interventions

DRUG

3 mg PF-06412562 MR tablets_Fasted

A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast

DRUG

2 x 15 mg PF-06412562 MR tablets_Fasted

Two 15 mg PF-06412562 modified release tablets administered after an overnight fast

DRUG

2 x 15 mg PF-06412562 MR tablets_Fed

Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast

DRUG

10 mg PF-06412562 IR tablets

a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT02201511 on ClinicalTrials.gov