A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants

Pfizer6 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

14C-PF-06826647-LR 600 mg PODRUG

14C-PF-06826647-LR 600 mg with 300 nCi orally as extemp prep

PF-06826647 600 mg PODRUG

Unlabeled PF-06826647 600 mg

14C-PF-06826647 100 ug IVDRUG

14C-PF-06826647 100 ug IV

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

PRA Health Sciences

Groningen, Netherlands

PRA Health Sciences Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose

Time frame: Up to Day 14

Secondary Outcomes

Number of Participants With Laboratory Test Values of Potential Clinical Importance

Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.

Time frame: Up to Day 28

Number of participants with abnormal ECG

Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to \<480 msec, 480 msec to \<500 msec or \>=500 msec and a maximum change of \<=30change\<60 or \>=60 msec from baseline.

Time frame: Up to Day 28

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.

Time frame: Up to Day 28

The ratio of dose normalized AUCinf of PF-06826647 and 14C-PF-06826647

The ratio of dose normalized AUCinf of PF-06826647 (LCMS) and 14C-PF-06826647 (AMS). AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time . It is obtained from AUC (0 - t) plus AUC (t - ∞).

Time frame: 0 hours to 96 hours

Data from ClinicalTrials.gov

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