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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Other: Placebo; Drug: PF-06835919

Study type: Interventional

Funder types: Industry

Identifiers

NCT02974374

C1061001

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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).

Trial design

16 participants in 2 patient groups, including a placebo group

PF-06835919

Experimental group

Treatment:

Drug: PF-06835919

Placebo

Placebo Comparator group

Treatment:

Other: Placebo