NCT01749085

Brief Summary

The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_1 healthy-volunteers

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

December 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

December 11, 2012

Last Update Submit

April 8, 2013

Conditions

Healthy Volunteers

Keywords

PF-04449913Food EffectDrug-drug interactionCYP3A4 inhibitorPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax)

    8 days

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

    8 days

Secondary Outcomes (5)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    8 days

  • Apparent Oral Clearance (CL/F)

    8 days

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    8 days

  • Apparent Volume of Distribution (Vz/F)

    8 days

  • Plasma Decay Half-Life (t1/2)

    8 days

Study Arms (2)

Sequence 1

EXPERIMENTAL
Drug: PF-04449913, ketoconazole

Sequence 2

EXPERIMENTAL
Drug: PF-04449913, ketoconazole

Interventions

PF-04449913, ketoconazoleDRUG

Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole

Sequence 1

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female subjects 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).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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
  • lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with one of the following currently in the past 6 months: myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias.
  • Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

glasdegibKetoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

US(1)