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A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
California Clinical Trials Medical Group
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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 and/or female subjects of non childbearing potential.

- Body Mass Index (BMI) of >=25 kg/m2; and a total body weight >50 kg

- Subjects with liver fat >=6% and

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).

NCT02855177
Pfizer
Completed
A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

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A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Assess The Safety, Tolerability, And Pharmacokinetics With 2-weeks Of Dosing Of Pf-06427878 In Overweight-obese, Otherwise Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Placebo
    Placebo as suspension administered every 8 hours, with food
  • Drug: PF-06427878
    500 mg suspension administered every 8 hours, with food
  • Placebo Comparator: Placebo
    Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
    Intervention: Drug: Placebo
  • Experimental: PF-06427878
    PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
    Intervention: Drug: PF-06427878
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 12, 2017
April 12, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of >=25 kg/m2; and a total body weight >50 kg
  • Subjects with liver fat >=6% and <=20%

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
United States
 
 
NCT02855177
B7871005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

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.

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1-800-718-1021

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Contact

[email protected]



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