Clinical trial NCT04591262: A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants
Official title: A PHASE 1, OPEN LABEL, 2-PERIOD, FIXED SEQUENCE, STUDY TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY OF 14C PF 06826647 IN HEALTHY MALE PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ADME, Mass Balance, Absolute Bioavailability, AMS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine the metabolism and excretion following a single oral administration of 14C-PF-06826647-LR (14C labelled PF-06826647 with lower radioactivity per mass unit) in fed conditions. This information will enable assessment of clearance mechanisms of PF-06826647 as well as identify metabolites. In addition, this study will determine absolute bioavailability of PF-06826647 and understand intravenous (IV) pharmacokinetic (PK).


Eligibility criteria: Inclusion Criteria:

* Healthy Male participants must be 18 to 55 years of age, inclusive.
* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including BP and pulse rate measurement, laboratory tests, and 12 lead ECG.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* BMI of 17.5 to 30 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* 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 irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation defined by less than 1 bowel movement on average per 2 days or lactose intolerance.
* Participants who currently use or have formerly used (within 6 months of dosing) tobacco or nicotine containing products.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.

Primary outcomes:
measure: Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose
timeFrame: Up to Day 14
Secondary outcomes:
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Up to Day 28
measure: Number of participants with abnormal ECG
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Up to Day 28
measure: The ratio of dose normalized AUCinf of PF-06826647 and 14C-PF-06826647
timeFrame: 0 hours to 96 hours
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: Utrecht
country: Netherlands
facility: PRA Health Sciences Utrecht
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: