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Healthy VolunteersPhase 1NCT03386279

A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

A Phase 1 study testing PF-04965842 and Moxifloxacin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

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 is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open, placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and moxifloxacin 400 mg (C). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PF-04965842 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteBelgium
Study dates
2 Jul 2018to 1 Oct 2018
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 female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead
  • ECG, or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
  • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • 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 (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).
  • Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • Subjects, who according to the product label for moxifloxacin, would be at increased risk if dosed with moxifloxacin (ie, including but not limited to subjects with history of myasthenia gravis, tendinitis/tendon rupture).
  • Self-reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug test.
Show all 25Show fewer
  • History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
  • Treatment 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 (whichever is longer).
  • Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-04965842.
  • Screening supine systolic BP <90 mm Hg or <140 mm Hg following at least 5 minutes of supine rest OR Screening supine diastolic BP <50 mm Hg or <90 mm Hg following at least 5 minutes of supine rest. If a subject meets any of these criteria, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
  • Screening supine 12-lead ECG demonstrating: QTcF >450 msec OR QRS interval >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF 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, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) <1.5 × upper limit of normal (ULN).
  • Total bilirubin level 1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ULN.
  • Known relevant history of elevated liver function tests (LFTs).
  • History of tuberculosis (TB) or active or latent or inadequately treated infection.
  • 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 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 1g/day. Limited use of nonprescription 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. Herbal supplements and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
  • Use of tobacco- or nicotine- containing products in excess of the equivalent of 5 cigarettes per day.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of hypersensitivity, allergy, severe adverse drug reaction or intolerance to quinolone antibiotics, including moxifloxacin.
  • 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 subject vaccination is permissible.
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of 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.
  • 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.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-04965842 ON QTC INTERVAL IN HEALTHY VOLUNTEERS

This is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open, placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and moxifloxacin 400 mg (C). Treatment assignments to PF-04965842 and placebo will be blinded to the subjects, investigator and Clinical Research Unit (CRU) staff (except pharmacist) but open to the sponsor. Moxifloxacin administration will be unblinded. Dosing in each of the 3 treatment periods will be separated by a washout period of at least 5 days

Screening evaluation will occur within the 28 days prior to dosing in the first treatment period. During each treatment period, eligible subjects who meet the entry criteria will be admitted on Day -1, prior to treatment administration on Day 1, and will reside in the CRU until completion of protocol assessments on Day 2. There will be a washout of at least 5 days between dose administrations in consecutive crossover treatment periods. After completion of the 3 study periods or upon withdrawal from the study, subjects will return for a follow-up visit approximately 7-14 days following last dose of investigational product. Further follow-up contact will be made at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product to capture any potential AEs and concomitant treatments, and to confirm appropriate contraception usage, contact with the subject may be done via phone. For each subject, the duration of participation from Day 1 admission to follow-up visit will be approximately 10 weeks. The follow-up call will occur up to 4 weeks after the follow-up visit.

In each treatment period, the subject will be admitted to the CRU the day prior to dosing. Genotyping samples for CYP2C19 and CYP2C9 will be collected pre-dose in Period 1 only. The subject will receive a single dose of the assigned trial medication in the morning of Day 1. Triplicate 12-lead ECG measurements (approximately 2 minutes apart) will be performed on Days 1 and 2 of each treatment period as follows: -1, -0.5 and 0 hours pre-dose and at 0.25, 0.5, 1, 2, 3, 6, 12, and 24 hours post-dose. Blood samples will be collected following the 0 hour and post-dose ECG measurements at the same time-points to evaluate the PK of PF-04965842 and moxifloxacin (if needed). Clinical safety laboratory tests will be performed on Day -1 and at 24 hours on Day 2, and vital signs (supine pulse rate and BP) will be monitored pre-dose and at 2 and 6 hours post-dose on Day 1 and at 24 hours on Day 2. The subject will be discharged from the CRU after completing all trial procedures of the particular treatment period in the morning of Day 2 (24 hours post-dose).

Being tested
PF-04965842, Moxifloxacin, Placebo
Keywords
healthy volunteers

What participants receive

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

  • PF-04965842Drug

    one single dose of 600 mg by mouth

  • MoxifloxacinDrug

    one single dose of 400 mg by mouth

  • PlaceboDrug

    one single dose by mouth

Study groups in NCT03386279
Study groupRoleWhat they receive
Sequence 1OtherSequential allocation to PF-04965842 600 mg (oral, single dose), placebo (oral, single dose), and moxifloxacin 400 mg (oral, single dose)
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo
Sequence 2OtherSequential allocation to PF-04965842 600 mg (oral, single dose), moxifloxacin 400 mg (oral, single dose), and placebo (oral, single dose)
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo
Sequence 3OtherSequential allocation to placebo (oral, single dose), PF-04965842 600 mg (oral, single dose), and moxifloxacin 400 mg (oral, single dose).
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo
Sequence 4OtherSequential allocation to placebo (oral, single dose), moxifloxacin 400 mg (oral, single dose), and PF-04965842 600 mg (oral, single dose)
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo
Sequence 5OtherSequential allocation to moxifloxacin 400 mg (oral, single dose), PF-04965842 600 mg (oral, single dose), and placebo (oral, single dose)
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo
Sequence 6OtherSequential allocation to moxifloxacin 400 mg (oral, single dose), placebo (oral, single dose) and PF-04965842 600 mg (oral, single dose)
Receives: Drug: PF-04965842; Drug: Moxifloxacin; Drug: Placebo

What is being measured

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

  1. Relationship between QTc change (msec) and PF-04965842 concentration

    Linear mixed effects modeling will be derived from ECGs and PK blood samples at the stated time points with an aim to demonstrate the lack of effect on QTc interval in healthy volunteers, of a supra-therapeutic concentration after administering a dose of 600 mg PF-04965842 compared with placebo.

    Measured: Zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose

Secondary outcomes (2)

  1. Relationship between QTc change (msec) and PF-04965842 concentration

    Linear mixed effects modeling will be derived from ECGs and PK blood samples at the stated time points. with an aim to demonstrate the lack of effect on QTc interval in healthy volunteers, of a therapeutic concentration after administering a dose of 600 mg PF-04965842 compared with placebo.

    Measured: Zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose

  2. Time matched mean differences in QTc between moxifloxacin and placebo

    Time matched mean differences in QTc between moxifloxacin and placebo at each post dose time point, including at the historical moxifloxacin Tmax of 3 hours.

    Measured: Zero hour (prior to zero hour treatment administration), and 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose

Timeline

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

  1. First posted29 Dec 2017
  2. Study start2 Jul 2018
  3. Primary completion1 Oct 2018
  4. Study completion1 Oct 2018

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386279
Sponsor's protocol ID
B7451027
Other IDs
2017-004472-61, 2017
Status last verified
Oct 2019
First submitted
21 Dec 2017
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.

    PubMed 35061234

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04965842 and Moxifloxacin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

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 8 inclusion and 25 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 14 Oct 2019. 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 Belgium. 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?

Relationship between QTc change (msec) and PF-04965842 concentration (time frame: Zero hour (prior to zero hour treatment administration), and at 0.25, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose). 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 NCT03386279, which also lists 1 linked publication.

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 14 Oct 2019.

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Clinical Trial NCT03386279 | AzTrials