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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04591262
Collaborator
(none)
6
Enrollment
2
Locations
1
Arm
2.6
Actual Duration (Months)
3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: 14C-PF-06826647-LR 600 mg PO
  • Drug: PF-06826647 600 mg PO
  • Drug: 14C-PF-06826647 100 ug IV
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Nov 10, 2020
Actual Primary Completion Date :
Jan 28, 2021
Actual Study Completion Date :
Jan 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Drug: PF-06826647 600 mg PO
Unlabeled PF-06826647 600 mg

Drug: 14C-PF-06826647 100 ug IV
14C-PF-06826647 100 ug IV

Outcome Measures

Primary Outcome Measures

  1. Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose [Up to Day 14]

Secondary Outcome Measures

  1. Number of Participants With Laboratory Test Values of Potential Clinical Importance [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 [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 [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 [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 - ∞).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences Groningen Netherlands 9728 NZ
2 PRA Health Sciences Utrecht Utrecht Netherlands 3584 BL

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04591262
Other Study ID Numbers:
  • C2501006
First Posted:
Oct 19, 2020
Last Update Posted:
Feb 21, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
ADME, Mass Balance, Absolute Bioavailability, AMS

Study Results

No Results Posted as of Feb 21, 2021