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Lorlatinib Renal Impairment Study

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female subjects of non-childbearing potential

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Demonstrate stable renal function

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

- Renal allograft recipients

- Any condition possibly affecting drug absorption (eg, gastrectomy)

- A positive urine drug test

- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
14 drinks/week for male subjects (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.

- Treatment 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
(whichever is longer).

- Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval
>450 msec or a QRS interval >120 msec

- Second-degree or third-degree AV block (unless paced) or baseline PR interval >180
msec at any time prior to dosing of study treatment.

- Abnormalities in clinical laboratory tests at screening

- Pregnant or breastfeeding female subjects

- History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin

- 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

NCT03542305
Pfizer
Not yet recruiting
Lorlatinib Renal Impairment Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Lorlatinib Renal Impairment Study
Official Title  ICMJE A PHASE 1, SINGLE DOSE OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF LORLATINIB IN SUBJECTS WITH IMPAIRED RENAL FUNCTION
Brief SummaryThis is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.
Detailed DescriptionThis is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment. Each subject will receive a single oral dose of lorlatinib administered in the fasted state. Subjects with mild, moderate, and severe renal impairment will be enrolled and normal healthy subjects will be enrolled as matched controls.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: Lorlatinib
Lorlatinib single oral dose
Study Arms  ICMJE
  • Experimental: Mild
    Mild renal impairment
    Intervention: Drug: Lorlatinib
  • Experimental: Moderate
    Moderate renal impairment
    Intervention: Drug: Lorlatinib
  • Experimental: Severe
    Severe renal impairment
    Intervention: Drug: Lorlatinib
  • Normal
    Normal renal function
    Intervention: Drug: Lorlatinib
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: May 18, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 9, 2019
Estimated Primary Completion DateOctober 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects of non-childbearing potential
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Demonstrate stable renal function

Exclusion Criteria:

  • Renal allograft recipients
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • A positive urine drug test
  • History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (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.
  • Treatment 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 (whichever is longer).
  • Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec
  • Second-degree or third-degree AV block (unless paced) or baseline PR interval >180 msec at any time prior to dosing of study treatment.
  • Abnormalities in clinical laboratory tests at screening
  • Pregnant or breastfeeding female subjects
  • History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03542305
Other Study ID Numbers  ICMJE B7461010
RENAL IMPAIRMENT ( Other Identifier: Alias Study 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 DateJuly 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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