Safety and Tolerability of PF-06818883 in Healthy Subjects

NCT03020784 | Terminated Phase 1 FDA Drug

• 1 other identifier: C0601001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Safety, Tolerability and Pharmacokinetics of PF-06818883

Conditions

Healthy

Keywords

acute neuroinflammatory

Outcome Measures

Primary Outcomes (6)

• Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  An assessment of Adverse Events

  Day 0, Day 1, Day 2, Day 3

• Change in Physical examination

  Safety test to check overall health

  Day 0, Day 1, Day 2 and Day 3

• Change in Neurological Exam

  Assessment of sensory neuron and motor responses

  Day 0, Day 1, Day 2 and Day 3

• Change in 12-lead ECG (electrocardiogram)

  heart's electrical activity recorded from electrodes on the body surface

  Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48

• Change in Vital signs

  clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions

  Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48

• Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)

  Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition

  Day 0, Day 2 and Day 3

Secondary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) after single dose for all periods

  Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48

• Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods

  Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods

  Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods

  Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48

• Plasma Decay Half-Life (t1/2) after single dose for all periods

  Day 1 hr 0.25, 0.5, 1, 1.5, 2, 3, 6, 8, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48

Study Arms (2)

Placebo

PLACEBO COMPARATOR

IV placebo

Drug: Placebo

PF-06818883

EXPERIMENTAL

Experimental drug

Drug: PF-06818883

Interventions

Placebo DRUG

Placebo

Placebo

PF-06818883 DRUG

Treatment

PF-06818883

Eligibility Criteria

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

You may qualify if:

• Healthy female subjects of nonchildbearing potential and/or male subjects
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any condition possibly affecting the placement of an intravenous drug administration line.
• A confirmed positive urine drug screen
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day
• Treatment with an investigational drug within 30 days (or as determined by the local requirement)
• Screening supine blood pressure \>140 mm Hg (systolic) or \<90 mm Hg (diastolic), following at least 5 minutes of supine rest
• Screening supine 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• History of human immunodeficiency virus (HIV), hepatitis B or C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb).
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product

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.

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, INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: January 13, 2017
• Study Start: November 11, 2016
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)