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

Last updated on November 20, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT02286882
Pfizer
Terminated
A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

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Descriptive Information
Brief Title  ICMJE A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
Official Title  ICMJE 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
Brief SummaryPF-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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: PF-06409577 or Placebo
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
Study Arms  ICMJE
  • Experimental: Cohort 1: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 2: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 3: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 4: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 5: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 6: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 7: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 8: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
  • Experimental: Cohort 9: PF-06409577 or placebo
    Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
    Intervention: Drug: PF-06409577 or Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 16, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2014)
56
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion DateJune 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02286882
Other Study ID Numbers  ICMJE B7881001
FIH ( Other Identifier: Alias Study Number )
2014-004022-18 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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