A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability And Pharmacokinetics Of Single, Escalating, Oral Doses Of Pf-06835919 In Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-06835919
- Conditions
- Non-alcoholic Fatty Liver Disease
- Sponsor
- Pfizer
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Subjects experiencing an Adverse Event
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of PF-06835919 in healthy adult subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males and female of non-childbearing potential;
- •Body Mass Index 21.5 to 30.5 kg/m2 (inclusive);
- •Total body weight \>50 kg (110 lbs).
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Arms & Interventions
PF-06835919
Intervention: PF-06835919
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Subjects experiencing an Adverse Event
Time Frame: Screening up to 28 days after last dose of study medication
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Secondary Outcomes
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06835919(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06835919(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Apparent Total Body Clearance (CL/F) for PF-06835919 (as permitted)(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06835919(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06835919 (as permitted)(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Time to Reach Maximum Observed Concentration for PF-06835919(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06835919 (as permitted)(0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose)