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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: PF-06252616; Biological: PF-06252161; Drug: Placebo

• Registration Number: NCT01616277
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-25
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	PF-06252616	-
4	Placebo	-
3	Placebo	-
1	PF-06252616	-
5	PF-06252616	Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
7	PF-06252616	-
5	Placebo	Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
2	Placebo	-
3	PF-06252161	-
6	PF-06252616	-
6	Placebo	-
7	Placebo	-
1	Placebo	-
2	PF-06252616	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay	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).	Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay	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.)	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)	Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)	Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)	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	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)	Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)	Through Day 197 post dosing
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA	Through Day 113 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)	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)	Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)	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.	Through Day 197 post dosing
Steady state volume of distribution is the apparent volume of distribution at steady-state.)	Through Day 197 post dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States