NCT03806101

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

January 14, 2019

Last Update Submit

May 2, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCinf of rosuvastatin.

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

    72 hrs after rosuvastatin administration in Period 1 and 2

  • CLr of rosuvastatin

    Renal clearance for rosuvastatin

    72 hrs after rosuvastatin administration in Period 1 and 2

Secondary Outcomes (9)

  • AUClast of rosuvastatin

    72 hours after rosuvastatin administration in Period 1 and 2

  • Tmax of rosuvastatin

    72 hours after rosuvastatin administration in Period 1 and 2

  • Cmax of rosuvastatin

    72 hours after rosuvastatin administration in Period 1 and 2

  • t1/2 of rosuvastatin

    72 hours after rosuvastatin administration in Period 1 and 2

  • Ae of rosuvastatin

    72 hours after rosuvastatin administration in Period 1 and 2

  • +4 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Single 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.

Drug: PF-04965842Drug: Rosuvastatin

Arm 2

EXPERIMENTAL

Single 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.

Drug: PF-04965842Drug: Rosuvastatin

Interventions

PF-04965842DRUG

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

Arm 1Arm 2
RosuvastatinDRUG

Single 10 mg dose of rosuvastatin

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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:
  • \. 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.
  • \. 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.
  • \. 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.
  • \. 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.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 35344588DERIVED

Related Links

MeSH Terms

Interventions

abrocitinibRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

January 23, 2019

Primary Completion

March 15, 2019

Study Completion

April 11, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)