NCT04591262

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

September 9, 2020

Last Update Submit

February 17, 2021

Conditions

Healthy

Keywords

ADME, Mass Balance, Absolute Bioavailability, AMS

Outcome Measures

Primary Outcomes (1)

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

    Up to Day 14

Secondary Outcomes (4)

  • Number of Participants With Laboratory Test Values of Potential Clinical Importance

    Up to Day 28

  • Number of participants with abnormal ECG

    Up to Day 28

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

    Up to Day 28

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

    0 hours to 96 hours

Study Arms (1)

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

EXPERIMENTAL

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 PODrug: PF-06826647 600 mg PODrug: 14C-PF-06826647 100 ug IV

Interventions

14C-PF-06826647-LR 600 mg PODRUG

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

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

Unlabeled PF-06826647 600 mg

PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IV
14C-PF-06826647 100 ug IVDRUG

14C-PF-06826647 100 ug IV

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

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

PRA Health Sciences Utrecht

Utrecht, 3584 BL, Netherlands

Location

Related Links

MeSH Terms

Interventions

ropsacitinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 19, 2020

Study Start

November 10, 2020

Primary Completion

January 28, 2021

Study Completion

January 28, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

NL(2)