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

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NCT02804399

Last updated on August 9, 2018
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FOR MORE INFORMATION
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

NCT02804399
Pfizer
Completed
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

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A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
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
The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.
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.
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • 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
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02804399
B7461011
RIFAMPIN DDI STUDY ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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