Dose Escalation Study of PF-06741086 In Healthy Subjects

August 10, 2016 updated by: Pfizer

A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects

This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.

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.
41

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

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

  • Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
  • Use of nicotine/tobacco products
  • Clotting disorders

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: Randomized
  • Masking: Triple

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: Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 2 (SC) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 3 (SC) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 4 (Intravenous [IV]) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 5 (IV) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 6 (IV) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 7 (IV) PF-06741086, Placebo
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
Drug: Placebo
Placebo for PF-06741086, single dose
Other Names:
  • saline placebo
Experimental: Cohort 8 (subcutaneous [SC]) PF-06741086
Biological: PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

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
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Percentage of subjects with laboratory abnormalities
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Number of subjects with change from baseline in vital signs
Time Frame: Day 1 up to Day 84
blood pressure, pulse rate, temperature, respiration rate
Day 1 up to Day 84
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Time Frame: Day 1 to Day 84
Day 1 to Day 84
Percentage of subjects with changes from baseline in physical examination
Time Frame: Day 1 to Day 84
Day 1 to Day 84
Percentage of subjects with infusion site reactions
Time Frame: Day 1 up to Day 7
Day 1 up to Day 7
Percentage of subjects with injection site reactions
Time Frame: Day 1 to Day 7
Day 1 to Day 7

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
Plasma PF-06741086 concentrations
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Time for Cmax (Tmax)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Area under the curve from time zero to last quantifiable concentration (AUClast)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Terminal half-life (t 1/2)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Volume of distribution at steady state (Vss)
Time Frame: Day 1 up to Day 84
Intravenous administration only
Day 1 up to Day 84
Apparent volume of distribution (Vz/F)
Time Frame: Day 1 up to Day 84
Subcutaneous administration only
Day 1 up to Day 84
Clearance (CL)
Time Frame: Day 1 up to Day 84
Intravenous administration only
Day 1 up to Day 84
Apparent clearance (CL/F)
Time Frame: Day 1 up to Day 84
Subcutaneous administration only
Day 1 up to Day 84
Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)]
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Mean residence time (MRT)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Total tissue factor pathway inhibitor concentrations over time
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Thrombin generation
Time Frame: Day 1 up to Day 84
may include lag time, peak thrombin generation, and endogenous thrombin generation potential
Day 1 up to Day 84
Prothrombin fragment 1+2 (PF1+2) concentrations over time
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
D-dimer concentrations over time
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Dilute prothrombin time (dPT)
Time Frame: Day 1 up to Day 84
Day 1 up to Day 84
Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production
Time Frame: Day 1 up to Day 84
Immunogenicity
Day 1 up to Day 84

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

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.
August 1, 2015

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.
July 1, 2016

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.
July 1, 2016

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).
August 3, 2015

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.
August 20, 2015

First Posted (Estimate)

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.
August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
August 12, 2016

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.
August 10, 2016

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.
August 1, 2016

More Information

Terms related to this study

Keywords

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.
  • B7841001
  • 2015-001821-17 (EudraCT Number)

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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