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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-06835919

Placebo

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Pfizer New Haven Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-06835919

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) for PF-06835919

Time to Reach Maximum Observed Concentration for PF-06835919

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06835919

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).

Plasma Decay Half-Life (t1/2) for PF-06835919 (as permitted)

Plasma Decay Half-Life (t1/2)

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.

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.

Full Information

NCT ID

NCT02974374

First Posted

October 11, 2016

Last Updated

December 13, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02974374

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06835919

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-06835919

Intervention Description

Single or repeated, escalating dose

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Single or repeated, escalating dose

Primary Outcome Measure Information:

Title

Number of Subjects experiencing an Adverse Event

Description

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.

Time Frame

Screening up to 28 days after last dose of study medication

Secondary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) for PF-06835919

Time Frame