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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 10 mg PF-06412562 IR tablets; Drug: 2 x 15 mg PF-06412562 MR tablets_Fed; Drug: 3 mg PF-06412562 MR tablets_Fasted; Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201511

2014-001214-25 (EudraCT Number)

B7441006

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non-childbearing potential 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).
• A positive urine drug screen.
• Subjects who have attempted suicide in the past.
• Subjects who have an unexplained history of sudden death in their family

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: 3 mg PF-06412562 MR tablets_Fasted

2

Experimental group

Treatment:

Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted

3

Experimental group

Treatment:

Drug: 2 x 15 mg PF-06412562 MR tablets_Fed

4

Experimental group

Treatment:

Drug: 10 mg PF-06412562 IR tablets