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A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492697
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: PF-06882961 Immediate Release Tablet Drug: PF-06882961 Controlled Release Tablet (long) Drug: PF-06882961 Controlled Release Tablet (short) Drug: PF-06882961 Immediate Release Solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label Study In Healthy Subjects To Evaluate The Pharmacokinetics Of Pf-06882961 Following Single Oral Administration Of Immediate Release Tablets And An Immediate Release Oral Solution In The Fed State, And Controlled Release Tablets In The Fed And Fasted States
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 18, 2018

Arm Intervention/treatment
Experimental: PF-06882961 Drug: PF-06882961 Immediate Release Tablet
Immediate Release Tablet

Drug: PF-06882961 Controlled Release Tablet (long)
Controlled Release tablet (long)

Drug: PF-06882961 Controlled Release Tablet (short)
Controlled Release tablet (short)

Drug: PF-06882961 Immediate Release Solution
PF-06882961 Immediate Release solution




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) for PF-06882961 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
  2. Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
  3. Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
  4. Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  5. Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24) [ Time Frame: 24 hours post dose in each period ]
  6. Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  7. Apparent clearance (CL/F) for PF-06882961, as data permit [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf

  8. Peak-to-trough (PTR) ratio for PF-06882961 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period ]
    Calculated as ratio of Cmax to C24


Secondary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (AEs) [ Time Frame: Baseline to at least 28 days after last dose ]
    Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements.

  2. AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]
  3. AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]
  4. Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]
  5. AUClast for PF-06882961 for CR tablet (long) in fed and fasted states [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]
  6. AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]
  7. Cmax for PF-06882961 for CR tablet (long) in fed and fasted states [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female subjects of nonchildbearing 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) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, 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 test.
  • History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects within 6 months before 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 investigational product (whichever is longer).
  • Subjects who have previously participated in prior studies with PF 06882961 as the investigational product.
  • Screening supine BP>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Screening supine 12 lead ECG demonstrating a QTc interval >450 msec or a QRS interval >120 msec.
  • Aspartate aminotransferase (AST) level >= 1.25 × upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) level >= 1.25 × ULN;
  • Total bilirubin level >=1.5 × ULN;
  • TSH > ULN;
  • HbA1c >=6.5%.
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for at least 28 days after the last dose of investigational product.
  • 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 investigational product
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or subjects with suspected MTC per the investigator's judgement.
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.
  • Subjects who are investigator 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, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492697


Locations
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United States, Connecticut
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03492697    
Other Study ID Numbers: C3421003
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No