A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Assessment of clinical laboratory tests.
Study Overview
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 of single oral doses of PF-06427878 in healthy adult subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and/or female subjects of non childbearing potential.
- •Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- •Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
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).
Arms & Interventions
Cohort 1-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06427878 (Drug)
Cohort 1-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: Placebo (Drug)
Cohort 2-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06427878 (Drug)
Cohort 2-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: Placebo (Drug)
Cohort 3-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: PF-06427878 (Drug)
Cohort 3-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of clinical laboratory tests.
Time Frame: 0-48 h post dose
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Time Frame: 0-48 h post dose
Assessment of adverse events (AEs).
Time Frame: 0-48 h post dose
Assessment of vital signs (including blood pressure and pulse rate).
Time Frame: 0-48 h post dose
Secondary Outcomes
- Maximum Observed Plasma Concentration (Cmax) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Apparent Oral Clearance (CL/F) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06427878(0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose)