Overview

This trial is active, not recruiting.

Condition healthy
Treatments pf-06252616, placebo, pf-06252161
Phase phase 1
Sponsor Pfizer
Start date June 2012
End date August 2014
Trial size 86 participants
Trial identifier NCT01616277, B5161001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
pf-06252616
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
placebo
Placebo for PF-06252616, IV infusion, single dose
(Placebo Comparator)
pf-06252616
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
placebo
Placebo for PF-06252616, IV infusion, single dose
(Placebo Comparator)
pf-06252161
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
placebo
Placebo for PF-06252616, IV infusion, single dose
(Placebo Comparator)
pf-06252616
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
placebo
Placebo for PF-06252616, Subcutaneous injection, single dose
(Placebo Comparator)
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
pf-06252616
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
placebo
Placebo for PF-06252616, IV infusion, repeat dose
(Placebo Comparator)
pf-06252616
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
placebo
Placebo for PF-06252616, IV infusion, single dose
(Placebo Comparator)
pf-06252616
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
placebo
Placebo for PF-06252616, IV infusion, single dose

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pfizer.