Clinical trial NCT02855177: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Number of Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Day -2 to Day 44
measure: Change from baseline in clinical laboratory tests
timeFrame: Day 1 to Day 22
measure: Change from baseline in vital signs
timeFrame: Day 0 to Day 22
measure: Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram
timeFrame: Day 0 to Day 22
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Apparent Oral Clearance (CL/F) of PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Peak:Trough ratio of PF-06427878 on day 14
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
measure: Amount of PF-06427878 excreted in urine (Ae) on day 14
timeFrame: 0-8 hours post dose
measure: Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14
timeFrame: 0-8 hours post dose
measure: Renal clearance of PF-06427878 (CLr) on day 14
timeFrame: 0-8 hours post dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.