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A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
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

1. Healthy female subjects of non-childbearing potential and/or 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. Female subjects of
non-childbearing potential must meet at least one of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; and have a serum follicle-stimulating hormone (FSH) level
confirming the post-menopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
females with tubal ligations) will be considered to be of childbearing potential.

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

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

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

5. Subject must be willing to avoid direct sunlight exposure or any high intensity
ultraviolet light exposure, from the first day of dosing with study medication and
until the follow-up visit; and to apply sun cream/lotion with a high sun protection
factor, as appropriate.

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

1. 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).

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

3. A positive urine drug screen.

4. History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for males (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.

5. 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).

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

7. Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec.
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 or QRS values should be used to determine the
subject's eligibility.

8. 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 aminotransferase
(SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic aminotransferase
(SGPT) >1.5 x upper limit of normal (ULN);

- Total bilirubin >1.5 x 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

9. Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; male subjects able to father children who are unwilling or unable
to use a highly effective method of contraception as outlined in this protocol for the
duration of the study and for at least 28 days after the last dose of investigational
product or longer based upon the compound's half-life characteristics.

10. 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 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.

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

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

13. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

14. 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.

15. 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.

16. Any subject considered at risk of suicide or self harm based on investigator judgement
and/or the details of a risk assessment.

17. Use of tobacco or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.

NCT02539550
Pfizer
Completed
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects

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A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects
A Phase 1, Placebo-controlled, Randomized, Subject- And Investigator-blind, Sponsor-open, Crossover Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06266047 After Administration Of Single Ascending Doses To Healthy Adult Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06266047 after first-time administration to healthy adult subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Placebo
    Placebo
  • Drug: PF-06266047
    PF-06266047
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06266047
    PF-06266047
    Intervention: Drug: PF-06266047
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2016
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy female subjects of non-childbearing potential and/or 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. Female subjects of non-childbearing potential must meet at least one of the following criteria:

    1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
    2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
  2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  5. Subject must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure, from the first day of dosing with study medication and until the follow-up visit; and to apply sun cream/lotion with a high sun protection factor, as appropriate.

Exclusion Criteria:

  1. 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).
  2. Any condition possibly affecting drug absorption (eg, gastrectomy).
  3. A positive urine drug screen.
  4. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (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.
  5. 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).
  6. Screening supine blood pressure >140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is >140 mm Hg (systolic) or >90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
  7. Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec. 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 or QRS values should be used to determine the subject's eligibility.
  8. 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 aminotransferase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic aminotransferase (SGPT) >1.5 x upper limit of normal (ULN);
    • Total bilirubin >1.5 x 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
  9. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product or longer based upon the compound's half-life characteristics.
  10. 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.
  11. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  12. History of sensitivity to heparin or heparin-induced thrombocytopenia.
  13. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  14. 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.
  15. 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.
  16. Any subject considered at risk of suicide or self harm based on investigator judgement and/or the details of a risk assessment.
  17. Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02539550
B7481001
2015-001796-52 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2016

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.

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1-800-718-1021

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[email protected]



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