Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855177
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: PF-06427878 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : August 24, 2016
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Drug: Placebo
Placebo as suspension administered every 8 hours, with food

Experimental: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Drug: PF-06427878
500 mg suspension administered every 8 hours, with food




Primary Outcome Measures :
  1. Number of Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Day -2 to Day 44 ]
  2. Change from baseline in clinical laboratory tests [ Time Frame: Day 1 to Day 22 ]
  3. Change from baseline in vital signs [ Time Frame: Day 0 to Day 22 ]
  4. Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram [ Time Frame: Day 0 to Day 22 ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  3. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  4. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  6. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  7. Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  8. Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  9. Apparent Oral Clearance (CL/F) of PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  10. Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  11. Peak:Trough ratio of PF-06427878 on day 14 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  12. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  13. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose ]
  14. Amount of PF-06427878 excreted in urine (Ae) on day 14 [ Time Frame: 0-8 hours post dose ]
  15. Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14 [ Time Frame: 0-8 hours post dose ]
  16. Renal clearance of PF-06427878 (CLr) on day 14 [ Time Frame: 0-8 hours post dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855177


Locations
Layout table for location information
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
United States, Florida
Qps-Mra, Llc
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02855177    
Other Study ID Numbers: B7871005
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by Pfizer:
Hyperlipidemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight