Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974374
• Other study ID #: C1061001
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2016
• Last updated: December 13, 2017
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• PF-06835919
Single or repeated, escalating dose

Other:
• Placebo
Single or repeated, escalating dose

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects experiencing an Adverse Event	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.	Screening up to 28 days after last dose of study medication
Secondary	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
Secondary	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
Secondary	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
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06835919	AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).	0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
Secondary	Plasma Decay Half-Life (t1/2) for PF-06835919 (as permitted)	Plasma Decay Half-Life (t1/2)	0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
Secondary	Apparent Total Body Clearance (CL/F) for PF-06835919 (as permitted)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after apparent total body clearance is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
Secondary	Apparent Volume of Distribution (Vz/F) for PF-06835919 (as permitted)	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose

External Links

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