A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-06409577 or Placebo
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male, or female subjects of non childbearing potential.
- •Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Arms & Interventions
Cohort 1: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 2: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 3: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 4: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 5: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 6: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 7: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 8: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Cohort 9: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06409577 or Placebo
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs)
Time Frame: 0-48 hours post dose
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Time Frame: 0-48 hours post dose
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: 0-48 hours post dose
Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
Time Frame: 0-48 hours post dose
Number of Participants With Echocardiogram Findings of Potential Clinical Importance
Time Frame: 0-48 hours post dose
Secondary Outcomes
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Oral Clearance (CL/F) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)(0-24 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Renal clearance for PF-06409577(0-24 hours post dose)
- Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)(0-24 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06409577(0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)