NCT01702506

Brief Summary

Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2012

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

Study Start

First participant enrolled

October 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

October 4, 2012

Last Update Submit

December 16, 2013

Conditions

Healthy Volunteers

Keywords

DacomitinibPF-00299804fedfastedantacidrelative Bioavailability

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). For dacomitinib and PF-05199265

    2 weeks

  • Maximum Observed Plasma Concentration (Cmax)

    For dacomitinib and PF-05199265

    2 weeks

Secondary Outcomes (6)

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

    2 weeks

  • Area under the Concentration-Time Curve (AUC)

    3 days

  • Apparent Oral Clearance (CL/F)

    2 weeks

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    2 weeks

  • Apparent Volume of Distribution (Vz/F)

    2 weeks

  • +1 more secondary outcomes

Study Arms (3)

Fasted

EXPERIMENTAL

Dacomitinib administered under fasted conditions

Drug: dacomitinib fasted

Fed

EXPERIMENTAL

Dacomitinib administered under fed conditions

Drug: dacomitinib fed

Antacid

EXPERIMENTAL

Dacomitinib administered under antacid treatment

Drug: dacomitinib+antacid

Interventions

dacomitinib fastedDRUG

Overnight fasted subjects will receive a single 45 mg dose of dacomitinib

Fasted
dacomitinib fedDRUG

Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal

Fed
dacomitinib+antacidDRUG

Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole

Antacid

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.

You may not qualify if:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Publications (1)

  • Ruiz-Garcia A, Masters JC, Mendes da Costa L, LaBadie RR, Liang Y, Ni G, Ellery CA, Boutros T, Goldberg Z, Bello CL. Effect of food or proton pump inhibitor treatment on the bioavailability of dacomitinib in healthy volunteers. J Clin Pharmacol. 2016 Feb;56(2):223-30. doi: 10.1002/jcph.588. Epub 2015 Oct 9.

    PMID: 26179237DERIVED

Related Links

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

HypoalphalipoproteinemiasHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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

October 4, 2012

First Posted

October 8, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

BE(1)