A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-06252616
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Incidence of abnormal lab findings.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
1
Intervention: PF-06252616
1
Intervention: Placebo
2
Intervention: PF-06252616
2
Intervention: Placebo
3
Intervention: PF-06252161
3
Intervention: Placebo
4
Intervention: PF-06252616
4
Intervention: Placebo
5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
Intervention: PF-06252616
5
Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
Intervention: Placebo
6
Intervention: PF-06252616
6
Intervention: Placebo
7
Intervention: PF-06252616
7
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence 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
Severity of treatment related Adverse Events.
Time Frame: Day 197
Incidence of treatment related Adverse Events.
Time Frame: Day 197
Magnitude of abnormal lab findings.
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
- 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)