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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: PF-06427878

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group
  • Florida
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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):eaav9701. doi: 10.1126/scitranslmed.aav9701.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2016
• Primary Completion (ACTUAL): April 12, 2017
• Study Completion (ACTUAL): April 12, 2017

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (ESTIMATE): August 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hyperlipidemia
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: B7871005