Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03765554
Previous Study | Return to List | Next Study

Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations

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: NCT03765554
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE January 7, 2019
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose ]
  • Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose ]
  • Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit [ Time Frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03765554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval [ Time Frame: Pre-dose and 48 hours post-dose ]
  • Change from baseline in heart rate [ Time Frame: Pre-dose and 48 hours post-dose ]
  • Change from baseline in blood pressure [ Time Frame: Pre-dose and 48 hours post-dose ]
  • Change from baseline in pulse rate [ Time Frame: Pre-dose and 48 hours post-dose ]
  • Change from baseline in oral temperature [ Time Frame: Pre-dose and 48 hours post-dose ]
  • Number of participants with laboratory abnormalities [ Time Frame: Baseline and 48 hours post-dose ]
  • Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs [ Time Frame: Baseline to 48 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations
Official Title  ICMJE A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE TABLETS COMPARED TO IMMEDIATE RELEASE TABLETS UNDER FASTED CONDITIONS
Brief Summary PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: PF-06700841 Immediate release tablets
    Small molecule tablets in immediate release form
  • Drug: PF-06700841 Modified release tablets
    Small molecule tablets in modified release form
Study Arms  ICMJE
  • Experimental: PF-06700841: IR followed by MR
    Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)
    Interventions:
    • Drug: PF-06700841 Immediate release tablets
    • Drug: PF-06700841 Modified release tablets
  • Experimental: PF-06700841: MR followed by IR
    Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)
    Interventions:
    • Drug: PF-06700841 Immediate release tablets
    • Drug: PF-06700841 Modified release tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2018)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 3, 2019
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, 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 and clinical laboratory tests).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Key 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 time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Have or have had clinically significant infections within the past 3 months prior to the first dose of investigational product (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days prior to the first dose of investigational product, herpes simplex within 12 weeks or history of disseminated herpes simplex infection, symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.
  • 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). As an exception, a positive hepatitis B surface antibody (HepBsAb) finding as a result of participant vaccination is permissible.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON tuberculosis (TB) Gold test.
  • Previous administration 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 used in this study (whichever is longer).
  • Female participants who are pregnant or wish to become pregnant; breastfeeding females.
  • Males/Females of childbearing potential 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.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03765554
Other Study ID Numbers  ICMJE B7931010
2018-003512-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP