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

Purpose

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.

Condition	Intervention	Phase
Healthy	Biological: PF-06252616 Drug: Placebo Biological: PF-06252161	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration) [ Time Frame: Through Day 197 post dosing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay [ Time Frame: Through Day 197 post dosing ] [ Designated as safety issue: No ]
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA [ Time Frame: Through Day 113 post dosing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time) [ Time Frame: Through Day 197 post dosing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Steady state volume of distribution is the apparent volume of distribution at steady-state.) [ Time Frame: Through Day 197 post dosing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	86
Study Start Date:	June 2012
Study Completion Date:	August 2014
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Placebo Comparator: 2	Biological: PF-06252616 3.0 milligram per kilogram of PF-06252616, IV infusion, single dose Drug: Placebo Placebo for PF-06252616, IV infusion, single dose
Placebo Comparator: 3	Biological: PF-06252161 10.0 milligram per kilogram of PF-06252616, IV infusion, single dose Drug: Placebo Placebo for PF-06252616, IV infusion, single dose
Placebo Comparator: 4	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
Placebo Comparator: 5 Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram	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
Placebo Comparator: 6	Biological: PF-06252616 20.0 milligram per kilogram of PF-06252616, IV infusion, single dose Drug: Placebo Placebo for PF-06252616, IV infusion, single dose
Placebo Comparator: 7	Biological: PF-06252616 40.0 milligram per kilogram of PF-06252616, IV infusion, single dose Drug: Placebo Placebo for PF-06252616, IV infusion, single dose

Eligibility


Ages Eligible for Study:	18 Years to 64 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616277

Locations


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

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01616277 History of Changes
Other Study ID Numbers:	B5161001
Study First Received:	May 25, 2012
Last Updated:	September 23, 2014
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 27, 2016