Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090047
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
An open-label, fixed-sequence, 2-period study to investigate the effect of multiple oral doses of itraconazole on a single oral dose of PF-06700841 PK in healthy participants. The study will consist of two treatment periods in one fixed sequence.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: PF-06700841 Drug: Itraconazole Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06700841 IN HEALTHY PARTICIPANTS
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : November 19, 2019
Estimated Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06700841 and Itraconazole
This fixed sequence, 2-period arm will consist of two treatments. Participants will receive a single oral dose of 30 milligrams (mg) PF-06700841 on Day 1 in Period 1. On Days 1-7 in Period 2, Itraconazole 200mg will be administered once daily(QD). On Day 4 of Period 2, co-administration of Itraconazole 200 mg and 30 mg PF-06700841 tablets will occur.
Drug: PF-06700841
PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose

Drug: Itraconazole
200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)
Other Name: Sporanox®




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  2. Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  3. Maximum Observed Plasma Concentration (Cmax) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: screening to last phone all follow up ]
    For male and women of non-childbearing potential (WONCBP), last phone call follow up is 28-35 days after last dose For women of childbearing potential (WOCBP), last phone call follow up is 60-65 days after last dose

  2. Incidence of Serious Adverse Events(SAE), and AEs leading to Discontinuation [ Time Frame: screening to last phone call follow up ]
    For male and women of non-childbearing potential (WONCBP), last phone call follow up is 28-35 days after last dose For women of childbearing potential (WOCBP), last phone call follow up is 60-65 days after last dose

  3. The incidence of clinically significant abnormalities in vital signs [ Time Frame: screening, pre-dose and 3 hours post-dose on Day 1 in Period 1; Pre-dose on Day 1, 3 hours post-dose on Day 4 and prior to discharge on Day 7 in Period 2 ]
  4. The incidence of clinically significant abnormalities in electrocardiograms(ECG) [ Time Frame: screening, pre-dose and 3 hours post-dose on Day 1 in Period 1; Pre-dose on Day 1, 3 hours post-dose on Day 4 and prior to discharge on Day 7 in Period 2 ]
  5. The incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: screening, Day -1 in Period 1 and prior to discharge in Period 2 ]
  6. Maximum plasma concentration(Cmax) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  7. Plasma (Tmax) time to reach Cmax of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  8. Terminal elimination half-life (t1/2) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  9. Apparent clearance (CL/F) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  10. Apparent volume of distribution(Vz/F) of PF-06700841 [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  11. Maximum plasma concentration(Cmax) of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  12. Plasma (Tmax) time to reach Cmax of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  13. Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  14. Metabolite/parent ratio (M/P) of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
  15. Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
    if data permit

  16. Terminal elimination half-life (t1/2) of PF-06700841 major metabolite (M1) [ Time Frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2 ]
    if data permit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 who are overtly healthy as determined by medical evaluation including a detailed medical history, full physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • Participant with a history of known hypersensitivity to itraconazole or its excipients or to other azole antifungals.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®- tuberculosis (TB) Gold or equivalent test.
  • Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
  • 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.
  • Have undergone significant trauma or major surgery within 4 weeks of Screening.
  • Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.Recombinant subunit vaccines (eg, Shingrix®) are permitted and it is preferable that the last dose is administered at least 4 weeks prior to Day 1.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • Female participants taking hormone replacement therapy within 28 days prior to the first dose of study treatment.
  • A positive urine drug test.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
  • Participants with abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • 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
  • Female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 60 days after the last dose of itraconazole.
  • Female nursing participants will be excluded.

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): NCT04090047


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04090047     History of Changes
Other Study ID Numbers: B7931033
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors