You are here

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

Last updated on August 9, 2018

FOR MORE INFORMATION
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy Volunteers
NCT03593707
All Genders
18+
Years
Brussels,
Healthy
NCT03599063
All Genders
18+
Years
New Haven, Connecticut
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
Drug: PF-06409577 or Placebo
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
June 2015
June 2015   (Final data collection date for primary outcome measure)

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)

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02286882
B7881001
FIH ( Other Identifier: Alias Study Number )
2014-004022-18 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now