A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06409577 or Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 2: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 3: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 4: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 5: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 6: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 7: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 8: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|
| Experimental: Cohort 9: PF-06409577 or placebo<br>Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. | Drug: PF-06409577 or Placebo<br>* PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) |  | 0-48 hours post dose | 
| Number of Participants With Laboratory Test Values of Potential Clinical Importance |  | 0-48 hours post dose | 
| Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance |  | 0-48 hours post dose | 
| Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance |  | 0-48 hours post dose | 
| Number of Participants With Echocardiogram Findings of Potential Clinical Importance |  | 0-48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577 | Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577 | AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Maximum Observed Plasma Concentration (Cmax) for PF-06409577 | Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577 | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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 | Plasma Decay Half-Life (t1/2) | 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 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 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 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 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) | Total amount of unchanged drug excreted in the urine over 24 hours. | 0-24 hours post dose | 
| Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24) | Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose. | 0-24 hours post dose | 
| Renal clearance for PF-06409577 | Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine. | 0-24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Ascending Dose, healthy subjects