A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

NCT02391623

Last updated date
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
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 17.5 to 35.4 kg/m2; and a total body weight >50 kg

- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
Brief Summary 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 of multiple oral doses of PF-06427878 in healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: PF-06427878
    PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
  • Drug: Placebo
    Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
  • Drug: PF-06427878
    PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
  • Drug: Placebo
    Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 2
    Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 3
    Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 4
    Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 5
    Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 6
    Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
Publications * Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520). pii: eaav9701. doi: 10.1126/scitranslmed.aav9701.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
60
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
  • Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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 NCT02391623
Other Study ID Numbers  ICMJE B7871002
2015-000130-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP