NCT02201511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1 month

First QC Date

July 24, 2014

Last Update Submit

November 9, 2015

Conditions

Healthy

Keywords

relative bioavailbilityfood effectpharmacokineticsALTERATION OF COGNITIVE FUNCTIONS

Outcome Measures

Primary Outcomes (6)

  • Maximum Observed Plasma Concentration (Cmax)

    0-2 days

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    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]

    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).

    0- 2 days

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

    0-2 days

  • Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    0-2 days

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: 3 mg PF-06412562 MR tablets_Fasted

2

EXPERIMENTAL
Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted

3

EXPERIMENTAL
Drug: 2 x 15 mg PF-06412562 MR tablets_Fed

4

EXPERIMENTAL
Drug: 10 mg PF-06412562 IR tablets

Interventions

3 mg PF-06412562 MR tablets_FastedDRUG

A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast

Arm 1
2 x 15 mg PF-06412562 MR tablets_FastedDRUG

Two 15 mg PF-06412562 modified release tablets administered after an overnight fast

2
2 x 15 mg PF-06412562 MR tablets_FedDRUG

Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast

3
10 mg PF-06412562 IR tabletsDRUG

a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

BE(1)