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A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

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NCT04092595

Last updated on December 10, 2019
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FOR MORE INFORMATION
Study Location
Brussels Clinical Research Unit
Brussels, Be-bru, B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and/or female participants who are healthy as determined by medical evaluation
including 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/m sq, and a total body weight greater than 50
kg (110 lb.).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing).

- Participants with any of the following acute or chronic infections or infection
history:

- Any infection requiring treatment within 2 weeks prior to the dosing visit.

- Any infection requiring hospitalization, parenteral antimicrobial therapy within 60
days of the first dose of rosuvastatin.

- Any infection judged to be an opportunistic infection or clinically significant by the
investigator, within the past 6 months of the first dose of rosuvastatin.

- Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other
infections.

- History of recurrent (more than one episode of) localized dermatomal herpes zoster, or
history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

- Known presence or a history of malignancy other than a successfully treated or excised
non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
situ.

NCT04092595
Pfizer
Recruiting
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
Official Title  ICMJE A PHASE 1, 2-PERIOD FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS
Brief SummaryA phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-06651600
    PF-06651600: 200 mg dose provided as four 50 mg oral tablets
  • Drug: Rosuvastatin
    10 mg oral tablet
    Other Name: Crestor ®
Study Arms  ICMJE Experimental: PF-06651600 and Rosuvastatin
Period 1 is 4 days in length. On Day 1 of Period 1 participants will receive a single dose of Rosuvastatin 10 mg given as a tablet orally. Period 2 is 11 days in length and will immediately follow Period 1 with no washout. In Period 2, participants will be dosed with oral 200 mg PF-06651600 once-daily (QD) for 7 days. On Day 8 of Period 2, a single dose of 10 mg Rosuvastatin oral tablet will be administered following administration of the 200-mg dose of PF-06651600. Dosing with oral 200 mg PF-06651600 QD will continue until Day 10 of Period 2.
Interventions:
  • Drug: PF-06651600
  • Drug: Rosuvastatin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2019)		12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2020
Estimated Primary Completion DateJanuary 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and/or female participants who are healthy as determined by medical evaluation including 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/m sq, and a total body weight greater than 50 kg (110 lb.).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Participants with any of the following acute or chronic infections or infection history:
  • Any infection requiring treatment within 2 weeks prior to the dosing visit.
  • Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days of the first dose of rosuvastatin.
  • Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of rosuvastatin.
  • Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
  • History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
  • Known presence or a history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092595
Other Study ID Numbers  ICMJE B7981024
2019-002536-85 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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