- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974374
Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects
December 13, 2017 updated by: Pfizer
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
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of PF-06835919 in healthy adult subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer New Haven Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Single or repeated, escalating dose
|
Experimental: PF-06835919
|
Single or repeated, escalating dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Screening up to 28 days after last dose of study medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) for PF-06835919
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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 Last Quantifiable Concentration (AUClast) for PF-06835919
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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
|
Plasma Decay Half-Life (t1/2) for PF-06835919 (as permitted)
Time Frame: 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)
|
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)
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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
|
Apparent Volume of Distribution (Vz/F) for PF-06835919 (as permitted)
Time Frame: 0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
November 22, 2016
First Posted (Estimate)
November 28, 2016
Study Record Updates
Last Update Posted (Actual)
December 15, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1061001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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