Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Completed
NCT Number: NCT01616277
A Phase 1 Study To Evaluate The Safety And Tolerability 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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
PF-06252616
Biological1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Placebo
DrugPlacebo for PF-06252616, IV infusion, single dose
PF-06252161
Biological10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Primary outcomes
-
Incidence of treatment related Adverse Events.
Time frame: Day 197
-
Severity of treatment related Adverse Events.
Time frame: Day 197
-
Incidence of abnormal lab findings.
Time frame: Day 197
-
Magnitude of abnormal lab findings.
Time frame: Day 197
-
Abnormal and clinically relevant changes in Blood Pressure.
Time frame: Day 197
-
Abnormal and clinically relevant changes in Pulse Rate.
Time frame: Day 197
-
Abnormal and clinically relevant changes in Respiratory Rate.
Time frame: Day 197
-
Abnormal and clinically relevant changes in temperature.
Time frame: Day 197
-
Abnormal and clinically relevant changes in ECG parameters.
Time frame: Day 197
Secondary outcomes
-
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Time frame: 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
-
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Time frame: 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
-
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
-
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
-
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
-
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
-
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
-
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Time frame: 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
-
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
-
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
-
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
-
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Time frame: 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
Sponsors and collaborators
Lead sponsor
Pfizer
Industry
Registry information
Official study title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 11, 2012
- Registry last updated
- Sep 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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