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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06409577 or Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: healthy subjects; Single Ascending Dose
• Other Study ID Numbers: B7881001; FIH (Other Identifier: Alias Study Number); 2014-004022-18 (EudraCT Number)