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Lorlatinib Renal Impairment Study

Last updated on July 8, 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.
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- 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.
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- 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
Recruiting
Lorlatinib Renal Impairment Study

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Renal Impairment
NCT03542305
All Genders
18+
Years
Multiple Sites

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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