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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 3 mg PF-06412562 MR tablets_Fasted; Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted; Drug: 2 x 15 mg PF-06412562 MR tablets_Fed; Drug: 10 mg PF-06412562 IR tablets

• Registration Number: NCT02201511
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Study Start: 2014-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	3 mg PF-06412562 MR tablets_Fasted	-
2	2 x 15 mg PF-06412562 MR tablets_Fasted	-
3	2 x 15 mg PF-06412562 MR tablets_Fed	-
4	10 mg PF-06412562 IR tablets	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	0-2 days
Time after dose and before the first plasma concentration (Tlag)	0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]	0- 2 days	AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	0-2 days	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Plasma Decay Half-Life (t1/2)	0-2 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0-2 days

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium