CompletedNCT02201511Updated Nov 10, 2015

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

A Phase 1 interventional study of 3 mg PF-06412562 MR tablets_Fasted and 2 x 15 mg PF-06412562 MR tablets_Fasted in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy

Keywords

relative bioavailbility
food effect
pharmacokinetics
ALTERATION OF COGNITIVE FUNCTIONS

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Arm 1
Drug: 3 mg PF-06412562 MR tablets_Fasted
Experimental
2
Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted
Experimental
3
Drug: 2 x 15 mg PF-06412562 MR tablets_Fed
Experimental
4
Drug: 10 mg PF-06412562 IR tablets

Interventions

Drug3 mg PF-06412562 MR tablets_Fasted
A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
Drug2 x 15 mg PF-06412562 MR tablets_Fasted
Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
Drug2 x 15 mg PF-06412562 MR tablets_Fed
Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
Drug10 mg PF-06412562 IR tablets
a single immediate release tablet of 10 mg PF-06412562 after an overnight fast

What researchers measure

Primary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-2 days
Time after dose and before the first plasma concentration (Tlag)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 0-2 days

Study locations

1 site

Pfizer Clinical Research Unit
Brussels, B-1070, Belgium

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02201511
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Jul 28, 2014
Start date: Sep 2014
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Nov 10, 2015

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Pfizer

Start the discussion