NCT02855177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2016

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

August 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

August 1, 2016

Last Update Submit

May 3, 2017

Conditions

Healthy Volunteers

Keywords

Hyperlipidemia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Drug: Placebo

PF-06427878

EXPERIMENTAL

PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Drug: PF-06427878

Interventions

PlaceboDRUG

Placebo as suspension administered every 8 hours, with food

Placebo
PF-06427878DRUG

500 mg suspension administered every 8 hours, with food

PF-06427878

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Related Publications (1)

  • 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.

    PMID: 31776293DERIVED

Related Links

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 4, 2016

Study Start

August 24, 2016

Primary Completion

April 12, 2017

Study Completion

April 12, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(2)