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HealthyPhase 1NCT03806101

Study of PF-04965842 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

A Phase 1 study testing PF-04965842 and Rosuvastatin in people with Healthy, 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, randomized, 2 way crossover, multiple dose, open label study of the effect of PF 04965842 on rosuvastatin PK in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. 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-04965842 and Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBelgium
Study dates
23 Jan 2019to 11 Apr 2019
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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age and Sex:
  • Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  • Type of Participant and Disease Characteristics:
  • Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, laboratory tests, and ECG.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
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  • Weight:
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Informed Consent:
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions:
  • 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 of acute exacerbation or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • Participants, who according to the product label for rosuvastatin, would be at increased risk if dosed with rosuvastatin.
  • 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.
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  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
  • A current or past medical history of conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
  • History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection; 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) as a result of participant vaccination is permissible.
  • 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 participant inappropriate for entry into this study.
  • Prior/Concomitant Therapy:
  • 10. 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.
  • 10. Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg, rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
  • 11. Use of CYP2C9 inhibitors (eg, amiodarone, felbamate, fluconazole, miconazole, piperine, diosmin, disulfiram, fluvastatin, fluvoxamine, voriconazole, efavirenz, isoniazid) or inducers (eg, aprepitant, carbamazepine, enzalutamide, rifampin, ritonavir, nevirapine, phenobarbital, and St. John's Wort) within 28 days or 5 half lives (whichever is longer) prior to dosing.
  • 12. Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
  • Prior/Concurrent Clinical Study Experience:
  • 13. 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).
  • Diagnostic Assessments:
  • 14. A positive urine drug test. 15. Screening supine systolic blood pressure (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 participant 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 participant's eligibility.
  • 16. 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 participant's eligibility.
  • 17. Participants 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:
  • Alkaline phosphatase, creatine kinase, aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) level > ULN.
  • Total bilirubin level > ULN; participants 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.
  • Estimated creatinine clearance <90 mL/min.
  • Confirmed microscopic proteinuria or hematuria.
  • Other Exclusions:
  • 18. History of regular alcohol consumption exceeding 14 drinks per week for female participants or 21 drinks per week for male participants (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.
  • 19. Known relevant history of elevated liver function tests (LFTs). 20. History of tuberculosis (TB) (active or latent) or inadequately treated TB infection. Positive QuantiFERON - TB Gold test.
  • 21. Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
  • 22. History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
  • 23. History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or considered clinically significant by the investigator within 6 months prior to screening.
  • 24. History of receiving a live vaccine within 6 weeks prior to the first dose of investigational product, or is expected to receive a live vaccine within 6 weeks after the last dose of investigational product.
  • 25. Have a known immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
  • 26. History of sensitivity to heparin or heparin induced thrombocytopenia. 27. Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • 28. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to first dose of investigational product.
  • 29. History of hypersensitivity to rosuvastatin. 30. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • 31. Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
  • 32. 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 Pfizer employees, including their family members, directly involved in the conduct of the 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, 2-WAY CROSSOVER, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-04965842 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS

This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of PF 04965842 on rosuvastatin PK in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 11 days and 10 nights (including Period 1 and Period 2). To adequately remove any drug effects of rosuvastatin from Period 1 to Period 2, there will be a minimum 5 day washout period between the 2 rosuvastatin dosing events.

Conditions
Healthy
Being tested
PF-04965842, Rosuvastatin

What participants receive

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

  • PF-04965842Drug

    200 mg dose of PF-04965842 once daily (QD) for 3 days

  • RosuvastatinDrug

    Single 10 mg dose of rosuvastatin

Study groups in NCT03806101
Study groupRoleWhat they receive
Arm 1ExperimentalSingle dose of rosuvastatin on Day 1 of Period 1 and Single dose of rosuvastatin on Day 1 + PF-04965842 on Days 1 to 3 of Period 2.
Receives: Drug: PF-04965842; Drug: Rosuvastatin
Arm 2ExperimentalSingle dose of rosuvastatin on Day 1 + PF-04965842 on Days 1 to 3 of Period 1 and single dose of rosuvastatin on Day 1 of Period 2.
Receives: Drug: PF-04965842; Drug: Rosuvastatin

What is being measured

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

  1. AUCinf of rosuvastatin.

    Area under the curve from time zero to extrapolated infinite time for rosuvastatin

    Measured: 72 hrs after rosuvastatin administration in Period 1 and 2

  2. CLr of rosuvastatin

    Renal clearance for rosuvastatin

    Measured: 72 hrs after rosuvastatin administration in Period 1 and 2

Secondary outcomes (9)

  1. AUClast of rosuvastatin

    Area under the plasma concentration time curve from 0 to the time of last measurement of rosuvastatin

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  2. Tmax of rosuvastatin

    Time to maximum concentration of rosuvastatin

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  3. Cmax of rosuvastatin

    Maximum observed plasma concentration for rosuvastatin

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  4. t1/2 of rosuvastatin

    apparent terminal half life of rosuvastatin

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  5. Ae of rosuvastatin

    Amount of rosuvastatin excreted in urine

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  6. Ae% of rosuvastatin

    Percent of dose of rosuvastatin excreted in urine

    Measured: 72 hours after rosuvastatin administration in Period 1 and 2

  7. Number of subjects with adverse events (AEs).

    Number of subjects with adverse events (AEs)

    Measured: Screening up to 28-35 days after the last dose of PF 04965842 in period 2

  8. Number of subjects with laboratory tests findings of potential clinical importance

    Number of subjects with laboratory tests findings of potential clinical importance

    Measured: Screening through Day 5 of period 2

  9. Number of subjects with clinically significant abnormal vital signs

    Number of subjects with clinically significant abnormal vital signs

    Measured: Screening through Day 5 of 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 posted16 Jan 2019
  2. Study start23 Jan 2019
  3. Primary completion15 Mar 2019
  4. Study completion11 Apr 2019

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806101
Sponsor's protocol ID
B7451033
Other IDs
2018-003425-28, DDI, 2018
Status last verified
May 2019
First submitted
14 Jan 2019
Last updated
6 May 2019
Results posted
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

  • Vourvahis M, Byon W, Chang C, Le V, Diehl A, Graham D, Tripathy S, Raha N, Luo L, Mathialagan S, Dowty M, Rodrigues AD, Malhotra B. Evaluation of the Effect of Abrocitinib on Drug Transporters by Integrated Use of Probe Drugs and Endogenous Biomarkers. Clin Pharmacol Ther. 2022 Sep;112(3):665-675. doi: 10.1002/cpt.2594. Epub 2022 May 9.

    PubMed 35344588

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04965842 and Rosuvastatin in people with Healthy, 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 10 inclusion and 41 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 6 May 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?

AUCinf of rosuvastatin. (time frame: 72 hrs after rosuvastatin administration in Period 1 and 2). The study lists 2 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 NCT03806101, 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 6 May 2019.

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