A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-03-31

Brief Summary

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This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single Ascending Doses Cohort 1

subjects receive 3 active doses and one placebo

Group Type EXPERIMENTAL

PF-06648671

Intervention Type DRUG

Experimental Pfizer compound which will be dosed as oral suspension

Placebo

Intervention Type DRUG

Placebo which will be given as oral suspension

Single Ascending Doses Cohort 2

subjects receive 3 doses and one placebo

Group Type EXPERIMENTAL

PF-06648671

Intervention Type DRUG

Experimental Pfizer compound which will be dosed as oral suspension

Placebo

Intervention Type DRUG

Placebo which will be given as oral suspension

Cohort 3

optional cohort

Group Type EXPERIMENTAL

PF-06648671

Intervention Type DRUG

Experimental Pfizer compound which will be dosed as oral suspension

Placebo

Intervention Type DRUG

Placebo which will be given as oral suspension

Interventions

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PF-06648671

Experimental Pfizer compound which will be dosed as oral suspension

Intervention Type DRUG

Placebo

Placebo which will be given as oral suspension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non childbearing potential
* BMI of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)
* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drg allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing);
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes