Absorption, Metabolism, Excretion and Absolute Bioavailability
NCT03250039
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
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. Subjects who are willing and able to comply with study confinement period, scheduled visits, treatment plan, laboratory tests, contraceptive requirements and other study procedures.
Subjects with any of the following characteristics/conditions will not be included in the
study:
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies).
2. Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
3. A positive urine drug screen for drugs of abuse or recreational drugs.
4. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).
5. History of abuse of alcohol 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
or more alcoholic drinks (male) in about 2 hours. As a general rule, alcohol intake
should not exceed 21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a
125 mL glass of wine).
6. Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
7. Treatment with an investigational drug within 60 days.
8. Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
9. Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure is >=140 mm Hg
(systolic) or >=90 mm Hg (diastolic), the blood pressure measurement should be
repeated two more times and the average of the three measurements should be used to
assess the subject's eligibility.
10. Supine 12 lead ECG demonstrating QTcF >450 msec or a QRS interval >120 msec at
screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be
repeated two more times and the average of the three QTcF or QRS values should be used
to determine the subject's eligibility.
11. Use of prescription or nonprescription drugs (including vitamins and dietary
supplements) within 7 days or 5 half lives (whichever is longer) prior to the first
dose of study medication. As an exception, acetaminophen may be used at doses of =<1
g/day. Limited use of non prescription medications that are not believed to affect
subject safety or the overall results of the study may be permitted on a case by case
basis following approval by Pfizer.
12. Use of herbal supplements within 28 days prior to the first dose of study medication.
13. Blood donation (excluding plasma donations) of no more than 100 mL or more within 56
days prior to dosing.
14. An estimated glomerular filtration rate of <90 mL/min/1.73 m2 based on the four
variable Modification of Diet in Renal Disease (MDRD) equation.
15. History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON TB Gold test.
16. Any medical history of disease (ie, Gilbert's disease) that has the potential to cause
a rise in total bilirubin over the upper limit of normal (ULN).
17. Subjects with ANY of the following abnormalities in clinical laboratory tests at
Screening, as assessed by the study specific laboratory and confirmed by a single
repeat, if deemed necessary:
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=1.5 ×
ULN, total serum bilirubin >= 25.6 micromol/L;
- Hemoglobin =<2.17 mmol/L (males).
18. Known participation in a clinical trial for PF 04965842 within 60 days prior to the
first dose of study medication.
19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients.
20. Unwilling or unable to comply with the Lifestyle Requirements described in this
protocol.
21. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.
22. Systemic therapy with any of the following medications that are CYP3A4 inhibitors
within 7 days or 5 half lives (whichever is longer) or CYP3A inducers within 28 days
prior to the first dose of the trial medication, or during the trial (Section 5.7).
23. History of sensitivity to heparin or heparin induced thrombocytopenia.
24. 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 subject inappropriate for entry into this
study.
25. Subjects with conditions that affect their ability to taste ie, dysgeusia, respiratory
infection, cold, etc.
26. Male subjects 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 90 days after the last dose of investigational product.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Haven, Connecticut
- Groningen,
- Utrecht,
- Paramus, New Jersey
- New Haven, Connecticut
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Absorption, Metabolism, Excretion and Absolute Bioavailability | ||||
Official Title ICMJE | A Phase 1, Open-label, Non-randomized, 2-period, Fixed Sequence Study To Investigate The Absorption, Metabolism And Excretion Of [14c-pf-04965842] And To Assess The Absolute Bioavailability And Fraction Absorbed Of Pf-04965842 In Healthy Male Subjects Using A 14c-microtracer Approach | ||||
Brief Summary | This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans. In addition, this study will provide a better understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV) clearance and delineating the extent of oral absorption (absolute bioavailability (F) and fraction absorbed (Fa)). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Intervention Model Description: This study will be an open label, non randomized, 2 period, fixed sequence, single dose study to characterize the absorption, metabolism and excretion of 14C- PF-04965842 and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-04965842 following oral administration of unlabeled PF-04965842 and IV and oral administration of 14C-PF-04965842 to healthy male subjects. Masking: None (Open Label)Primary Purpose: Other | ||||
Condition ICMJE | Healthy | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
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 | Completed | ||||
Actual Enrollment ICMJE | 6 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 15, 2017 | ||||
Actual Primary Completion Date | September 15, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria Subjects with any of the following characteristics/conditions will not be included in the study:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03250039 | ||||
Other Study ID Numbers ICMJE | B7451008 2017-000461-73 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |