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HealthyPhase 1NCT02883114

An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.

A Phase 1 study testing PF-06648671 and Itraconazole in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single dose administration in healthy subject. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-06648671 and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Sep 2016to Nov 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and/or female subjects of non childbearing potential 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 or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • 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).
  • Hypersensitivity or previous adverse events due to azole antifungals.
  • A positive urine drug testing.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of Screening.
  • Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication, whichever is longer.
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  • Screening supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is >=140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
  • Screening supine 12 lead ECG demonstrating corrected QT (QTc) >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
  • Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening AND at Day 0, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:
  • Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >1x upper limit of normal (ULN);
  • Total bilirubin>=1.5 x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ULN.
  • Fertile male subjects 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, or longer based upon the compound's half life characteristics, 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. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
  • History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV). As an exception, a positive HBsAb finding as a result of subject vaccination is permissible.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • Unwilling or unable to comply with the Lifestyle Requirements described in this 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.
  • Any condition possibly affecting drug absorption.
  • Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Two-period, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Single-dose Pharmacokinetics Of Pf-06648671 In Healthy Adults

This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single dose administration in healthy subject.

Read the detailed description

Based on in vitro data, PF-06648671 was predominantly metabolized by CYP3A and therefore there is a potential risk that PF-06648671 PK will be affected by co-administered drugs that can inhibit CYP3A activity. This is a clinical drug interaction study to evaluate this potential drug interaction in human. In this study, healthy volunteers will take a single dose of 25 mg PF-06648671 in period 1 followed by at least 7 day washout. In period 2, same subjects will take 200 mg itraconazole oral solution once a day for 3 days, followed by co-administration of 200 mg oral solution and a single dose of 25 mg PF-06648671 on day 4 which are dosed approximately one hour apart with itraconazole is given first. The PF-06648671 PK will be collected 0-48 hours after dose in period 1 and 0-240 hrs in period 2. Safety will also be monitored throughout both periods.

Conditions
Healthy
Being tested
PF-06648671, Itraconazole
Keywords
PF-06648671, GSM, CYP3A, drug interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06648671Drug

    Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2.

  • ItraconazoleDrug

    Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2

Study groups in NCT02883114
Study groupRoleWhat they receive
single cohortExperimentalsingle dose of PF-06648671 in period 1 and 14-day dose of itraconazole plus single dose of PF-06648671 in period 2
Receives: Drug: PF-06648671; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed PF-06648671 Plasma Concentration (Cmax)

    Camx after single dose of 25 mg PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2 following single dose PF-06648671

  2. Time to Reach Maximum Observed Plasma concentration (Tmax)

    Tmax following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)

    AUCinf following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

  4. Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)

    AUClast following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

  5. Plasma Decay Half-life (t1/2)

    t1/2 following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

  6. Apparent Oral Clearance (CL/F)

    CL/F following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

  7. Apparent Volume of Distribution (Vz/F)

    Vz/F following single doses of PF-06648671 in period 1 and period 2

    Measured: 0-48 hours in period 1 and 0-240 hours in period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02883114
Sponsor's protocol ID
B7991006
Status last verified
Dec 2016
First submitted
25 Aug 2016
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06648671 and Itraconazole in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed PF-06648671 Plasma Concentration (Cmax) (time frame: 0-48 hours in period 1 and 0-240 hours in period 2 following single dose PF-06648671). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02883114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.

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