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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 25 mg PF-06412562; Drug: 10 mg PF-06412562; Drug: PF-06412562 TBD mg; Drug: 3 mg PF-06412562

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959594

B7441002

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Treatment:

Drug: 3 mg PF-06412562

Cohort 2

Experimental group

Treatment:

Drug: 10 mg PF-06412562

Cohort 3

Experimental group

Treatment:

Drug: 25 mg PF-06412562

Optional Cohort 4

Experimental group

Treatment:

Drug: PF-06412562 TBD mg

Drug: PF-06412562 TBD mg

Optional Cohort 5

Experimental group

Treatment:

Drug: PF-06412562 TBD mg

Drug: PF-06412562 TBD mg