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Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

Last updated on August 8, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Anderlecht, , Route de Lennik 808, 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adult, Drug Interactions, Healthy Volunteers, Humans
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.
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- Male and female participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, laboratory tests, and ECG.

- Adequate Renal Function, including:

Estimated creatinine clearance ≥90 mL/min as calculated using chronic kidney disease
epidemiology collaboration equation (CKD EPI). In equivocal cases, a 24 hour urine
collection test can be used to estimate the creatinine clearance more accurately.

- Adequate Liver Function, including: Total serum bilirubin within normal limits (WNL).
Aspartate and Alanine aminotransferase (AST and ALT) WNL. Alkaline phosphatase WNL.

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

- Male participants of childbearing potential must agree to use a highly effective
method of contraception from the first screen throughout the study and for 97 days
after the last dose of assigned treatment if male participant. A participant is of
childbearing potential if, in the opinion of the investigator, he/she is biologically
capable of having children and is sexually active.

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

- Capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the informed consent
document (ICD) and in this

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

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

- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HepBsAg), or hepatitis C
antibody (HCVAb). A positive hepatitis B surface antibody (HepBsAb) serology
indicating Hepatitis B vaccination is allowed.

- 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 or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study. Psychiatric adverse experiences have been reported in patients treated
with modafinil with many, but not all, with prior psychiatric history. Participants
with a history of psychosis, depression, or mania are excluded from this study.

- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of
investigational product. As an exception, acetaminophen/paracetamol may be used at
doses of ?1 g/day. Limited use of nonprescription medications that are not believed to
affect participant safety or the overall results of the study may be permitted on a
case by case basis following approval by the sponsor.

- Previous administration with lorlatinib within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of lorlatinib used in this study
(whichever is longer).

- Previous treatment with lorlatinib

- A positive urine drug test, as confirmed by a single repeat.

- Screening supine blood pressure (BP) ?130 mm Hg (systolic) or ?80 mm Hg (diastolic),
following at least 5 minutes of supine rest. If BP is ?130 mm Hg (systolic) or ?80 mm
Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP
values should be used to determine the participant's eligibility.

- History of pancreatitis (elevated amylase or lipase) or hyperlipidemia.

- Screening supine 12 lead ECG demonstrating PR interval >200 msec, corrected QT (QTc)
>450 msec or a QRS interval >120 msec.

- History of cardiac arrhythmia (excluding asymptomatic sinus arrhythmia with heart rate
>50, and occasional asymptomatic premature atrial contraction and premature
ventricular contractions), history of atrioventricular (AV) block, history of
symptomatic bradycardia, history of QTc prolongation.

- Participants with ANY of the following abnormalities in clinical laboratory tests at
screening: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >
upper limit of normal (ULN); Total bilirubin level > ULN; participants with a history
of Gilbert's syndrome may have direct bilirubin measured and would be eligible for
this study provided the direct bilirubin level is ? ULN.

- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week for males or 7 units per week for
females (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces
(90 mL) of wine).

- As modafinil is a controlled substance, participants with a history drug abuse will be
excluded.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

- History of sensitivity to lorlatinib or modafinil.

- Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

- Male participants with partners currently pregnant; male participants able to father
children who are unwilling or unable to use a highly effective method of contraception
as outlined in this protocol for the duration of the study and for at least 97 days
after the last dose of investigational product or longer based upon the compound's
half life characteristics, and refrain from sperm donation for the duration of the
study and for at least 97 days after the last dose of investigational product.

- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT03961997
Pfizer
Not yet recruiting
Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

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[email protected]

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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

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[email protected]

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