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OpenTrials
Completed

NCT Number: NCT02485769

Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Oral Pf-06650833 In Healthy Subjects

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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 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 for females or 14 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.
  • Smokers must not exceed the equivalent of 5 cigarettes per day.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  • Screening supine blood pressure100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If blood pressure (BP) is 40 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.
  • Screening pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR is >100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility.
  • Screening 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.
  • Clinically significant abnormality on chest X ray performed at screening or within 3 months of screening date.
  • History of tuberculosis or active or latent or inadequately treated infection, positive Quantiferon TB test
  • History of hepatitis or HIV, positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HepBsAg), hepatitis B core antibodies (HepBcAb) or hepatitis C antibodies (HCVAb).

Treatment and study plan

PF-06650833

Drug

Suspension

Placebo

Drug

Suspension

Primary outcomes

  1. Incidence and severity of treatment emergent adverse events.

    Time frame: 50 days

  2. Incidence and Magnitude of Participants with Treatment-emergent hematology clinical abnormalities

    Time frame: 50 days

  3. Incidence and Magnitude of Participants with Treatment-emergent chemistry abnormalities (including, cardiac enzymes CK, CK-MB and cardiac Troponin-1, serum myoglobin)

    Time frame: 50 days

  4. Incidence and Magnitude of Participants with Treatment-emergent urinalysis abnormalities

    Time frame: 50 Days

  5. Changes from baseline in blood pressure

    Time frame: 50 days

  6. Changes from baseline in pulse rate

    Time frame: 50 days

  7. Changes from baseline in respiratory rate

    Time frame: 50 days

  8. Changes from baseline in ECG parameters (standard 12-lead ECG)

    Time frame: 50 days

  9. Changes from baseline in Epstein-Barr virus [EBV]

    Time frame: 50 days

  10. Changes from baseline in Cytomegalovirus [CMV]

    Time frame: 50 days

  11. Changes from baseline in Herpes simplex virus-1 and -2 [HSV-1 and HSV-2]

    Time frame: 50 days

Secondary outcomes

  1. To characterize Cmax in plasma

    Time frame: Day 1 and Day 14

  2. To determine PF-06650833 excreted unchanged (AE tau and AE tau %),

    Time frame: Day 14

  3. To characterize Tmax in plasma

    Time frame: Day 1 and Day 14

  4. To characterize AUC tau in plasma

    Time frame: Day 1 and Day 14

  5. To characterize Cmin in plasma

    Time frame: Day 1 and Day 14

  6. Characterize Cmax (dose normalized) in plasma

    Time frame: Day 1 and Day 14

  7. To characterize AUC tau(dose normalized) in plasma

    Time frame: day1 and day 14

  8. To determine the renal clearance (CLr)

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered Pf 06650833 In Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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