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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591262
• Other study ID #: C2501006
• Status: Completed
• Phase: Phase 1
• Start date: November 10, 2020
• Est. completion date: January 28, 2021

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 14C-PF-06826647-LR 600 mg PO
14C-PF-06826647-LR 600 mg with 300 nCi orally as extemp prep
• PF-06826647 600 mg PO
Unlabeled PF-06826647 600 mg
• 14C-PF-06826647 100 ug IV
14C-PF-06826647 100 ug IV

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
Netherlands	PRA Health Sciences Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose		Up to Day 14
Secondary	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.	Up to Day 28
Secondary	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.	Up to Day 28
Secondary	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.	Up to Day 28
Secondary	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 - 8).	0 hours to 96 hours

External Links

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