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

NCT04090047 | Completed Phase 1 FDA Drug

• 1 other identifier: B7931033
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Heathy Participants

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841

  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

• Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841

  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

• Maximum Observed Plasma Concentration (Cmax) of PF-06700841

  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 Outcomes (16)

• Incidence of treatment-emergent adverse events (TEAE)

  screening to last phone all follow up

• Incidence of Serious Adverse Events(SAE), and AEs leading to Discontinuation

  screening to last phone call follow up

• The incidence of clinically significant abnormalities in vital signs

  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

• The incidence of clinically significant abnormalities in electrocardiograms(ECG)

  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

• The incidence of clinically significant abnormalities in clinical laboratory values

  screening, Day -1 in Period 1 and prior to discharge in Period 2

Study Arms (1)

PF-06700841 and Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

Interventions

PF-06700841 DRUG

PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose

PF-06700841 and Itraconazole

Itraconazole DRUG

200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)

Also known as: Sporanox®

PF-06700841 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06700841; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 24, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)