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Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers

Last updated on March 15, 2019

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Study Location
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
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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1. Healthy (no clinically relevant abnormalities) males, 18 to 55 years at the time of
screening.

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

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

4. Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures.

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

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

3. A positive urine drug test.

4. History of regular alcohol consumption exceeding 14 drinks/week within 6 months before
screening.

5. Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the dose of investigational product (whichever
is longer).

6. Screening BP ? 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5
minutes of rest. If systolic or diastolic BP is higher at screening, repeat 2 times
and use average of 3 BP values.

7. Screening supine 12 lead ECG QTc interval >450 msec or QRS interval >120 msec, or PR
interval > 180 msec. If QTc or QRS exceed, ECG should be repeated 2 more times and the
average of the 3 QTc or QRS should be used.

8. Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening (and confirmed with single repeat): AST or ALT level > 1.0 × ULN; Total
bilirubin level > 1.5 × ULN. If history of Gilbert's syndrome, subject would be
eligible provided the direct bilirubin level is ? ULN.

9. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to study drug dose. Acetaminophen may be used
at dosed up to 1 g/day. Limited use of nonRx medications may be permitted following
approval by the sponsor. Herbal supplements and hormone replacement therapy must have
been discontinued at least 28 days prior to study drug dose.

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

11. History of HIV, hepatitis B, or hepatitis C; positive testing for HIV, HepBsAg,
HepBcAb, or HCVAb.

12. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section.

13. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members supervised by the investigator, or subjects
who are Pfizer employees, including their family members, directly involved in the
conduct of the study.

14. 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.

15. History of irregular bowel movements eg, regular episodes of diarrhea or constipation,
irritable bowel syndrome or lactose intolerance.

16. Enrolled in a previous radionucleotide study or who have received radiotherapy within
12 months prior to screening or such that total radioactivity would exceed acceptable
dosimetry (ie, occupational exposure of 5 rem per year).

17. Subjects whose occupation requires exposure to radiation or monitoring of radiation
exposure.

18. Subjects who have used tobacco within 90 days prior to dosing.

19. Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use 2 highly effective methods of contraception as
outlined in this protocol for the duration of the study and for at least 90 days after
the last dose of investigational product.

NCT03184168
Pfizer
Completed
Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers

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[email protected]

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