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

• ClinicalTrials.gov Identifier: NCT01616277
• Recruitment Status: Completed
• First Posted: June 11, 2012
• Last Update Posted: September 25, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Biological: PF-06252616; Drug: Placebo; Biological: PF-06252161	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: June 2012
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment related Adverse Events. [ Time Frame: Day 197 ]
2. Severity of treatment related Adverse Events. [ Time Frame: Day 197 ]
3. Incidence of abnormal lab findings. [ Time Frame: Day 197 ]
4. Magnitude of abnormal lab findings. [ Time Frame: Day 197 ]
5. Abnormal and clinically relevant changes in Blood Pressure. [ Time Frame: Day 197 ]
6. Abnormal and clinically relevant changes in Pulse Rate. [ Time Frame: Day 197 ]
7. Abnormal and clinically relevant changes in Respiratory Rate. [ Time Frame: Day 197 ]
8. Abnormal and clinically relevant changes in temperature. [ Time Frame: Day 197 ]
9. Abnormal and clinically relevant changes in ECG parameters. [ Time Frame: Day 197 ]

Secondary Outcome Measures :

1. PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration) [ Time Frame: Through Day 197 post dosing ]
2. 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 ]
3. Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay [ Time Frame: Through Day 197 post dosing ]
4. Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA [ Time Frame: Through Day 113 post dosing ]
5. 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 ]
6. 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 ]
7. 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 ]
8. 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 ]
9. 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 ]
10. PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time) [ Time Frame: Through Day 197 post dosing ]
11. 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 ]
12. 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 ]
13. 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 ]
14. 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 ]
15. Steady state volume of distribution is the apparent volume of distribution at steady-state.) [ Time Frame: Through Day 197 post dosing ]
16. 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

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

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. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01616277
• Other Study ID Numbers: B5161001
• First Posted: June 11, 2012
• Last Update Posted: September 25, 2014
• Last Verified: September 2014