Back to resultsA Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
PF-06427878
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring Hyperlipidemia
Eligibility 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).
Sites / Locations
- California Clinical Trials Medical Group
- Qps-Mra, Llc
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PF-06427878
Arm Description
Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Outcomes
Primary Outcome Measures
Number of Treatment Emergent Treatment-Related Adverse Events (AEs)
Change from baseline in clinical laboratory tests
Change from baseline in vital signs
Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14
Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14
Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14
Apparent Oral Clearance (CL/F) of PF-06427878 on day 14
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14
Peak:Trough ratio of PF-06427878 on day 14
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1
Amount of PF-06427878 excreted in urine (Ae) on day 14
Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14
Renal clearance of PF-06427878 (CLr) on day 14
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02855177
Brief Title
A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
April 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Hyperlipidemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Arm Title
PF-06427878
Arm Type
Experimental
Arm Description
PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo as suspension administered every 8 hours, with food
Intervention Type
Drug
Intervention Name(s)
PF-06427878
Intervention Description
500 mg suspension administered every 8 hours, with food
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame
Day -2 to Day 44
Title
Change from baseline in clinical laboratory tests
Time Frame
Day 1 to Day 22
Title
Change from baseline in vital signs
Time Frame
Day 0 to Day 22
Title
Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram
Time Frame
Day 0 to Day 22
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Peak:Trough ratio of PF-06427878 on day 14
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Title
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
Title
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
Title
Amount of PF-06427878 excreted in urine (Ae) on day 14
Time Frame
0-8 hours post dose
Title
Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14
Time Frame
0-8 hours post dose
Title
Renal clearance of PF-06427878 (CLr) on day 14
Time Frame
0-8 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31776293
Citation
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):eaav9701. doi: 10.1126/scitranslmed.aav9701.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7871005&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled%2C+Parallel-group+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+With+2-weeks+Of+Dosing+Of+Pf-06427878+In+Overweight-obese%2C+Otherwise+Healthy+Adult+Subjects
Description
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A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
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