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Trial record 61 of 7709 for:    Area Under Curve

A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

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ClinicalTrials.gov Identifier: NCT04111614
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).

Condition or disease Intervention/treatment Phase
Healthy Drug: Tofacitinib tablet Drug: Tofacitinib Oral Solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2 PERIOD, CROSS OVER, SINGLE DOSE STUDY TO DEMONSTRATE THE AREA UNDER THE CURVE EQUIVALENCE BETWEEN TOFACITINIB ORAL SOLUTION FORMULATION AND TABLET FORMULATION UNDER FASTED CONDITION IN HEALTHY PARTICIPANTS
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : December 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Single dose of 5 mL tofacitinib oral solution on Day 1 of Period 1 and Singe dose of 5 mg tofacitinib tablet on Day 1 of Period 2
Drug: Tofacitinib tablet
Single dose of tofacitinib 5 mg tablet

Drug: Tofacitinib Oral Solution
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)

Experimental: Arm 2
Single dose of 5 mg tofacitinib tablet on Day 1 of Period 1 and Singe dose of 5 mL tofacitinib oral solution on Day 1 of Period 2
Drug: Tofacitinib tablet
Single dose of tofacitinib 5 mg tablet

Drug: Tofacitinib Oral Solution
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)




Primary Outcome Measures :
  1. AUCinf for tofacitinib oral solution and tofacitinib tablet [ Time Frame: 24 hrs after study drug administration in Period 1 and Period 2 ]
    Area under the curve from time zero to extrapolated infinite time for both oral solution and tofacitinib.

  2. AUClast for tofacitinib oral solution and tofacitinib tablet [ Time Frame: 24 hrs after study drug administration in Period 1 and Period 2 ]
    Area under the plasma concentration time curve from 0 to time of the last measurement of both the tofacitinib oral solution and tofacitinib tablet.


Secondary Outcome Measures :
  1. Cmax for tofacitinib oral solution and tofacitinib tablet [ Time Frame: 24 hrs after study drug administration in Period 1 and Period 2 ]
    Maximum observed plasma concentration for tofacitinib oral solution and tofacitinib tablet

  2. Number of subjects with adverse events (AEs). [ Time Frame: Screening to up to 28-35 days after the last dose of study medication in Period 2. ]
    Number of subjects with adverse events (AEs).

  3. Number of subjects with laboratory tests findings of potential clinical importance [ Time Frame: Screening through Day 2 of Period 2 ]
    Number of subjects with laboratory tests findings of potential clinical importance

  4. Number of subjects with clinically significant abnormal vital signs [ Time Frame: Screening through Day 2 of Period 2 ]
    Number of subjects with clinically significant abnormal vital signs

  5. Number of subjects with clinically significant physical examination findings [ Time Frame: Screening to Day 2 of Period 2 ]
    Number of subjects with clinically significant physical examination findings.



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:

  • Male and female participants of non childbearing potential must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  • Male and female participants of non-childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure (BP), pulse rate, oral temperature, and 12 lead electrocardiogram (ECG).
  • Body mass index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight greater than 50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Clinically significant infections within the past 3 months prior to the baseline visit (for example, those requiring hospitalization or parenteral antibiotics, or as judged by the investigator), evidence of any infection within the past 7 days prior to the baseline visit, history of disseminated herpes simplex infection or recurrent (>1 episode) herpes zoster or disseminated herpes zoster.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • Malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • A positive urine drug test.

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): NCT04111614


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Connecticut
New Haven Clinical Research Unit Recruiting
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: NCT04111614     History of Changes
Other Study ID Numbers: A3921354
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/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
Additional relevant MeSH terms:
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Pharmaceutical Solutions
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action