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Completed

NCT Number: NCT04591262

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences, Groningen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-PF-06826647-LR 600 mg PO

Drug

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

PF-06826647 600 mg PO

Drug

Unlabeled PF-06826647 600 mg

14C-PF-06826647 100 ug IV

Drug

14C-PF-06826647 100 ug IV

Primary outcomes

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

    Time frame: Up to Day 14

Secondary outcomes

  1. Number of Participants With Laboratory Test Values of Potential Clinical Importance

    Time frame: Up to Day 28

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

  2. Number of participants with abnormal ECG

    Time frame: Up to Day 28

    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.

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

    Time frame: Up to Day 28

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

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

    Time frame: 0 hours to 96 hours

    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 - ∞).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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