A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

3 mg PF-06412562

Intervention Type DRUG

oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days

Cohort 2

Group Type EXPERIMENTAL

10 mg PF-06412562

Intervention Type DRUG

oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days

Cohort 3

Group Type EXPERIMENTAL

25 mg PF-06412562

Intervention Type DRUG

oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days

Optional Cohort 4

Group Type EXPERIMENTAL

PF-06412562 TBD mg

Intervention Type DRUG

oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts

Optional Cohort 5

Group Type EXPERIMENTAL

PF-06412562 TBD mg

Intervention Type DRUG

oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts

Interventions

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3 mg PF-06412562

oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days

Intervention Type DRUG

10 mg PF-06412562

oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days

Intervention Type DRUG

25 mg PF-06412562

oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days

Intervention Type DRUG

PF-06412562 TBD mg

oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts

Intervention Type DRUG

PF-06412562 TBD mg

oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* 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 judgment 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