Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT03184168
Eligibility Criteria:
Inclusion Criteria:
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:
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03184168
Study Brief:
Protocol Section:
NCT03184168