A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

September 23, 2014 updated by: Pfizer

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects

The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.

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 (Anticipated)

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.
86

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

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 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
  • Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.

Exclusion Criteria:

  • Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
  • Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.

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
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Placebo Comparator: 2
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 1
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 4
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 3
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252161
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 6
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 7
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo Comparator: 5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
Biological: PF-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
Drug: Placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
Biological: PF-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
Drug: Placebo
Placebo for PF-06252616, IV infusion, repeat dose
Biological: PF-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Biological: PF-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose

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
Time Frame
Incidence of treatment related Adverse Events.
Time Frame: Day 197
Day 197
Severity of treatment related Adverse Events.
Time Frame: Day 197
Day 197
Incidence of abnormal lab findings.
Time Frame: Day 197
Day 197
Magnitude of abnormal lab findings.
Time Frame: Day 197
Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Time Frame: Day 197
Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Time Frame: Day 197
Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Time Frame: Day 197
Day 197
Abnormal and clinically relevant changes in temperature.
Time Frame: Day 197
Day 197
Abnormal and clinically relevant changes in ECG parameters.
Time Frame: Day 197
Day 197

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
Time Frame
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
Time Frame: Through Day 113 post dosing
Through Day 113 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
Time Frame: Through Day 197 post dosing
Through Day 197 post dosing

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.

General Publications

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.
June 1, 2012

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.
August 1, 2014

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.
August 1, 2014

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).
May 25, 2012

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.
June 7, 2012

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.
June 11, 2012

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.
September 25, 2014

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.
September 23, 2014

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.
September 1, 2014

More Information

Terms related to this study

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.
  • B5161001

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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