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

NCT02974374 | Completed Phase 1

• 1 other identifier: C1061001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06835919

  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)

  0, 0.33, 1, 2, 3, 4, 5, 6, 8,10, 12, 16, 24, and 48 hours post dose

Study Arms (2)

PF-06835919

EXPERIMENTAL

Drug: PF-06835919

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PF-06835919 DRUG

Single or repeated, escalating dose

PF-06835919

Placebo OTHER

Single or repeated, escalating dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related 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.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

PF-06835919

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 28, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

US (1)