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Completed

NCT Number: NCT03448172

Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages of 18 and 45 years, inclusive.
  • Body mass index (BMI) of >= 17.5 and <= 30.4 kg/m2
  • Total body weight > 50 kg (110 lb).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Treatment and study plan

[14C]PF-05221304

Drug

a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)

Primary outcomes

  1. Mass Balance

    Time frame: 0-96 hr

    Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered

Secondary outcomes

  1. Metabolic profiling for PF-05221304 in plasma, urine, and feces

    Time frame: 0-96 hr

    Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces

  2. Radioactivity AUClast

    Time frame: 0-96 hr

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity

  3. Plasma PF-05221304 AUClast

    Time frame: 0-96 hr

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304

  4. Radioactivity AUCinf

    Time frame: 0-96 hr

    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for radioactivity

  5. Plasma PF-05221304 AUCinf

    Time frame: 0-96 hr

    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304

  6. Radioactivity Cmax

    Time frame: 0-96 hr

    Maximum Observed Plasma Concentration (Cmax) for radioactivity

  7. Plasma PF-05221304 Cmax

    Time frame: 0-96 hr

    Maximum Observed Plasma Concentration (Cmax) for PF-05221304

  8. Radioactivity Tmax

    Time frame: 0-96 hr

    Time to Reach Maximum Observed Plasma Concentration for radioactivity

  9. Plasma PF-05221304 Tmax

    Time frame: 0-96 hr

    Time to Reach Maximum Observed Plasma Concentration for PF-05221304

  10. Radioactivity t1/2

    Time frame: 0-96 hr

    Plasma Decay Half-Life (t1/2) for radioactivity

  11. Plasma PF-05221304 t1/2

    Time frame: 0-96 hr

    Plasma Decay Half-Life (t1/2) for PF-05221304

  12. Number of subjects experiencing an adverse event

    Time frame: Up to 28 days post dosing of IP on Day 1

    Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG.

    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity. Treatment-emergent are events between dosing with study drug and up to 28 days after that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2018
Registry last updated
Dec 4, 2018

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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