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

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ClinicalTrials.gov Identifier: NCT02391623
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 12, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 2, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Assessment of adverse events (AEs). [ Time Frame: 0-25 days ]
  • Assessment of clinical laboratory tests. [ Time Frame: 0-25 days ]
  • Assessment of vital signs (including blood pressure and pulse rate). [ Time Frame: 0-25 days ]
  • Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [ Time Frame: 0-25 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  • Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]
  • Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]
  • Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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