MedDataX Logo

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

NCT ID: NCT02974374

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of PF-06835919 in healthy adult subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-alcoholic Fatty Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-06835919

Group Type EXPERIMENTAL

PF-06835919

Intervention Type DRUG

Single or repeated, escalating dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single or repeated, escalating dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-06835919

Single or repeated, escalating dose

Intervention Type DRUG

Placebo

Single or repeated, escalating dose

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1061001&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo+Controlled+Study+To+Assess+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Single%2C+Escalating%2C+Oral+Doses+Of+Pf-06835919+In+Healthy+Adult+Subjects

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1061001&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Single%2C+Escalating%2C+Oral+Doses+Of+Pf-06835919+In+Healthy+Adult+Subjects

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C1061001

Identifier Type: -

Identifier Source: org_study_id