A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

April 21, 2016 updated by: Pfizer

A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male subjects.
Healthy non-child bearing female subjects.
18 to 35 years of age.

Exclusion Criteria:

Heart disease.
Clotting disorders.
Use of nicotine products.
Diabetes.

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: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-05230907 and Placebo Cohort 1	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Experimental: PF-05230907 and Placebo Cohort 2	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Experimental: PF-05230907 and Placebo Cohort 3	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Experimental: PF-05230907 and Placebo Cohort 4	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Experimental: PF-05230907 and Placebo Cohort 5	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
Experimental: PF-05230907 and Placebo Cohort 6	Biological: PF-05230907 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 1 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 2 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 3 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose Biological: PF-05230907 5 micrograms per kilogram of PF-05230907, IV bolus, single dose Drug: Placebo for PF-05230907 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose limiting treatment related adverse events Time Frame: Through Day 43	Through Day 43
Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events Time Frame: Through Day 43	Through Day 43
Incidence and magnitude of treatment emergent abnormal laboratory findings Time Frame: Through Day 43	Through Day 43
Change from baseline in vital sign measurements, ECG parameters, and physical examinations Time Frame: Through Day 43	Through Day 43

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Time Frame: Through 4 hour post dose Day 1	Through 4 hour post dose Day 1
Maximum Observed Plasma Concentration (Cmax) Time Frame: Through 4 hour post dose Day 1	Through 4 hour post dose Day 1
Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR) Time Frame: Through post dose Day3	Through post dose Day3
Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) Time Frame: Through post dose Day3	Through post dose Day3
Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes Time Frame: Through post dose Day 2	Through post dose Day 2
Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2) Time Frame: Through post dose Day 2	Through post dose Day 2
Pharmacodynamic activity as measured by D-dimer Time Frame: Through post dose Day 7	Through post dose Day 7
Pharmacodynamic activity as measured by protein C activity Time Frame: Through post dose Day 2	Through post dose Day 2
Pharmacodynamic activity as measured by Factor V activity Time Frame: Through post dose Day 3	Through post dose Day 3
Incidence of antibody immune response Time Frame: Through post dose Day 43	Through post dose Day 43
Factor X activity Time Frame: Through post dose Day 43	Through post dose Day 43

Collaborators and Investigators

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

Sponsor

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

To obtain contact information for a study center near you, click here.

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

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

B2341001
2013-001387-36 (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.

Clinical Trials on Healthy

University of Vermont Medical Center
Avocado Nutrition Center

Recruiting

Avocado and Postprandial Responses

Healthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokers

United States
Dragonfly Therapeutics

Recruiting

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults (DF5112)

Healthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult Male

Australia
University of Palermo

Completed

Neck Static Stretching Acutely Reduces Blood Pressure Through Reduction of Tissue Stiffness

Healthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | Stretching

Italy
Prevent Age Resort "Pervaya Liniya"

Recruiting

First Line Prevent Age Study (FLIPS)

Healthy Aging | Healthy Diet | Healthy Lifestyle

Russian Federation
Umm Al-Qura University

Active, not recruiting

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

Healthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult Subjects

Saudi Arabia
Maastricht University Medical Center

Completed

Reference Gait Data for Healthy Subjects

Healthy Volunteers | Healthy Subjects | Healthy Adults

Netherlands
University of Palermo

Completed

Roller Massage and Blood Pressure

Healthy Participants | Healthy Adult Participants | Healthy Young Adults

Italy
Yale University

Not yet recruiting

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

Healthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol

United States
Pfizer

Not yet recruiting

A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults

Healthy | Healthy Adults

United States
Atisama Therapeutics

Recruiting

Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers

Healthy | Healthy Smoker

Australia

Clinical Trials on PF-05230907

Pfizer

Terminated

Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Intracerebral Hemorrhage

Spain, United States, Canada, United Kingdom
Pfizer

Completed

Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Healthy

United States
Pfizer

Completed

To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

Healthy

United Kingdom
University of Florida

Completed

Potato Fiber and Gastrointestinal Function: Phase 3

Gastrointestinal Symptoms | Stool Frequency | Gastrointestinal Transit Time

United States
Pfizer

Completed

A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy

Healthy Volunteer

United States
Pfizer

Completed

A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

Healthy

United States
Pfizer

Completed

A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

Schizophrenia

United States
Pfizer

Terminated

Study to Learn About How the Study Medicines Called PF-07976016 and PF-06882961 Are Taken Up by the Body, and if Either of Them Change How the Body Processes the Other Medicine in Otherwise Healthy Adults With Overweight or Obesity

Obesity | Overweight

United States
Pfizer

Completed

A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.

Healthy

United States
Pfizer

Completed

Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) (MIRNA)

Nonalcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis With Liver Fibrosis

Hong Kong, United States, Taiwan, Puerto Rico, China, Canada, Korea, Republic of, Bulgaria, Japan, India, Poland, Slovakia

A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on PF-05230907

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations