Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

March 5, 2019 updated by: Pfizer

A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • PRA Health Sciences
      • Utrecht, Netherlands, 3584 BL
        • PRA Health Sciences Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Exclusion Criteria:

  • Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
  • Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
  • Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
  • Use of herbal supplements within 28 days prior to the first dose of study medication
  • Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Pfizer
  • Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
  • Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2-period, fixed sequence
fixed sequence with 2 treatment period
Drug: Oral PF-06700841 containing 14C microtracer
Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
Drug: Oral unlabeled PF-06700841
60 mg unlabeled PF-06700841 oral dose in 2nd period
Drug: IV 14C-labeled PF-06700841
30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mass balance_urine
Time Frame: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
hour 0 up to 312 hours post dose
mass balance_feces
Time Frame: hour 0 up to 312 hours post dose
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
hour 0 up to 312 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
metabolite identification_plasma
Time Frame: hour 0 up to 312 hours post dose
metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Cmax for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Tmax for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma AUClast for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma AUCinf for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
Oral clearance for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma half-life for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
volume of distribution for total 14C radioactivity
Time Frame: hour 0 up to 312 hours post dose
apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
plasma Cmax for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma Tmax for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUClast for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUCinf for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
Oral clearance for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma half-life for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
volume of distribution for PF-06700841
Time Frame: hour 0 up to 96 hours post dose
apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
hour 0 up to 96 hours post dose
plasma Cmax for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma Tmax for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUClast for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma AUCinf for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
clearance for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
plasma half-life for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
volume of distribution for 14C-labeled PF-06700841
Time Frame: hour 0 up to 96 hours post dose
volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
hour 0 up to 96 hours post dose
unchanged PF-06700841 recovered in urine
Time Frame: hour 0 up to 96 hours post dose
percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841
hour 0 up to 96 hours post dose
renal clearance of PF-06700841
Time Frame: hour 0 up to 96 hours post dose
renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)
hour 0 up to 96 hours post dose
Bioavailability of oral PF-06700841
Time Frame: hour 0 up to 96 hours post dose
Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841
hour 0 up to 96 hours post dose
Fraction absorbed of oral PF-06700841
Time Frame: hour 0 up to 144 hours post dose
Fraction absorbed in gut (Fa) following oral dose of PF-06700841
hour 0 up to 144 hours post dose
metabolite identification_urine
Time Frame: hour 0 up to 312 hours post dose
metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose
metabolite identification_feces
Time Frame: hour 0 up to 312 hours post dose
metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841
hour 0 up to 312 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7931014
  • 2018-002403-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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