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A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects who, at the time of screening, are 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 or clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 the time of dosing).

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces
[150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor)
within 6 months of Screening.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer).

- Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure is 140 mm Hg (systolic)
or 90 mm Hg (diastolic), the blood pressure should be repeated two more times and the
average of the three blood pressure values should be used to determine the subject's
eligibility.

- Screening supine 12-lead ECG demonstrating QTcF (time from ECG Q wave to the end of
the T wave corresponding to electrical systole [QT] corrected for the heart rate using
the Fredericia's formula) >450 msec or a QRS interval (time from ECG Q wave to the end
of the S wave corresponding to ventricle depolarization) >120 msec. If QTcF exceeds
450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the
average of the three QTcF or QRS values should be used to determine the subject's
eligibility.

- Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat, if deemed necessary:

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or
alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) 3 x
upper limit of normal (ULN);

- Total bilirubin ? 1.5x ULN; subjects with a history of Gilbert's syndrome may
have a direct bilirubin measured and would be eligible for this study provided
the direct bilirubin is ? ULN.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of study medication. As an
exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of
non-prescription medications that are not believed to affect subject safety or the
overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor.

Herbal supplements and hormone replacement therapy must be discontinued at least 28 days
prior to the first dose of study medication.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.

- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

- Subjects with a history of irregular bowel movements eg, regular episodes of diarrhea
or constipation, irritable bowel syndrome (IBS) or lactose intolerance.

- Subjects enrolled in a previous radionucleotide study or who have received
radiotherapy within 12 months prior to screening or such that total radioactivity
would exceed acceptable dosimetry (ie, occupational exposure of 5 rem per year).

- Subjects whose occupation requires exposure to radiation or monitoring of radiation
exposure.

- Subjects who have used tobacco within 90 days prior to dosing.

- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use 2 highly effective methods of contraception as
outlined in this protocol for the duration of the study and for at least 90 days after
the last dose of investigational product or longer based upon the compound's half life
characteristics.

NCT02564562
Pfizer
Completed
A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers

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A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers
A Phase 1 Open-Label, Radiolabeled, Single-Dose Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers
The study aims to understand, using radiolabelled PF-06463922, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: [14C] PF-06463922
Single oral dose of 100mg PF-06463922 + [14C] PF-06463922
Experimental: Treatment
Radiolabeled PF-06463922 in healthy volunteers
Intervention: Drug: [14C] PF-06463922
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects who, at the time of screening, are 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 or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

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 the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
  • Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the blood pressure should be repeated two more times and the average of the three blood pressure values should be used to determine the subject's eligibility.
  • Screening supine 12-lead ECG demonstrating QTcF (time from ECG Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for the heart rate using the Fredericia's formula) >450 msec or a QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF or QRS values should be used to determine the subject's eligibility.
  • Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:

    • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) 3 x upper limit of normal (ULN);
    • Total bilirubin ? 1.5x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ? ULN.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication.

  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  • Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects with a history of irregular bowel movements eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance.
  • Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rem per year).
  • Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
  • Subjects who have used tobacco within 90 days prior to dosing.
  • Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product or longer based upon the compound's half life characteristics.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02564562
B7461004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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