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CompletedNCT02539550Updated Jun 24, 2016

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

A Phase 1 interventional study of Placebo and PF-06266047 in Healthy Volunteers, 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 2016-06-24.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06266047 after first-time administration to healthy adult subjects.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • PF-06266047
  • safety
  • tolerability
  • pharmacokinetics
  • first-in-human
  • healthy volunteers
  • PDE4
  • phosphodiesterase-4
03

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.

04

Who can participate

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

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

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 \<ULN.
  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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Experimental
    PF-06266047

    PF-06266047

    Drug: PF-06266047

Interventions

  • DrugPlacebo

    Placebo

  • DrugPF-06266047

    PF-06266047

06

What researchers measure

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Number of participants with AEs occurring after first dose of study drug. Relatedness to study drug will be assessed by investigator.

    Time frame: Baseline up to 1 day of dosing

  2. Number of subjects with standard safety laboratory test results of potential clinical significance

    Number of subjects with standard safety laboratory test results of potential clinical significance (according to pre-defined criteria).

    Time frame: Baseline up to 1 day of dosing

  3. Electrocardiogram (ECG)

    Absolute values and changes from baseline for the ECG parameters

    Time frame: 0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

  4. Orthostatic blood pressure and pulse rate

    Absolute values and changes from baseline for blood pressure and pulse rate

    Time frame: 0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

  5. Abnormal rhythms as observed on continuous cardiac telemetry

    All abnormal rhythms will be reviewed by the study physician for the presence of rhythms of potential clinical concern. The time, duration and description of any clinically significant event will be recorded.

    Time frame: Baseline period of at least 2 hours and continuous tracing for at least 8 hours following single dose administration

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

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

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

  5. 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, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

  6. Apparent Oral Clearance (CL/F)

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

  7. Apparent Volume of Distribution (Vz/F)

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

    Time frame: 0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose

07

Study locations

1 site
  • Pfizer Clinical Research Unit
    Bruxelles, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02539550
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 3, 2015
Start date
Aug 2015
Primary completion
May 2016
Completion
May 2016
Last update
Jun 24, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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