A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

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NCT02804399

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-254-6398
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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

- Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

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, neurologic, or
allergic disease


- Any condition possibly affecting drug absorption


- Positive urine drug screen


- History of HIV, Hep B or Hep C


- History of regular alcohol consumption


- History of cardiac arrhythmia, history of AV block, history of symptomatic
bradycardia, history of QTc prolongation


- History of pancreatitis or hyperlipidemia, elevated lipase

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Official Title  ICMJE A Phase One, Open Label, Two-period, Two-treatment, Fixed Sequence, Cross-over Study To Estimate The Effect Of Multiple Dose Rifampin On The Single Dose Pharmacokinetics Of Pf-06463922 In Healthy Volunteers.
Brief Summary The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.
Detailed Description This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06463922
    100 mg oral dose on day 1 in period 1 and on day 8 in period 2
    Other Name: lorlatinib
  • Drug: rifampin
    600 mg QD from day 1 to day 12 in period 2.
    Other Name: rifampicin
Study Arms  ICMJE Experimental: all subjects
subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses.
Interventions:
  • Drug: PF-06463922
  • Drug: rifampin
Publications * Chen J, Xu H, Pawlak S, James LP, Peltz G, Lee K, Ginman K, Bergeron M, Pithavala YK. The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants. Adv Ther. 2020 Feb;37(2):745-758. doi: 10.1007/s12325-019-01198-9. Epub 2019 Dec 20. Erratum in: Adv Ther. 2020 Sep 10;:.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2016)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption
  • Positive urine drug screen
  • History of HIV, Hep B or Hep C
  • History of regular alcohol consumption
  • History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
  • History of pancreatitis or hyperlipidemia, elevated lipase
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804399
Other Study ID Numbers  ICMJE B7461011
RIFAMPIN DDI STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP