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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-01-28

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IV

PF-06826647 600 mg single dose in Period 1 followed by PF-06826647 600 mg PO and IV infusion of 100 ug of PF-06826647 in Period 2.

Group Type EXPERIMENTAL

14C-PF-06826647-LR 600 mg PO

Intervention Type DRUG

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

PF-06826647 600 mg PO

Intervention Type DRUG

Unlabeled PF-06826647 600 mg

14C-PF-06826647 100 ug IV

Intervention Type DRUG

14C-PF-06826647 100 ug IV

Interventions

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14C-PF-06826647-LR 600 mg PO

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

Intervention Type DRUG

PF-06826647 600 mg PO

Unlabeled PF-06826647 600 mg

Intervention Type DRUG

14C-PF-06826647 100 ug IV

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes