Clinical trial NCT03020784: Safety and Tolerability of PF-06818883 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single-ascending Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-06818883 Following Single Intravenous Administration In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: acute neuroinflammatory
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Safety, Tolerability and Pharmacokinetics of PF-06818883


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day 0, Day 1, Day 2, Day 3
measure: Change in Physical examination
timeFrame: Day 0, Day 1, Day 2 and Day 3
measure: Change in Neurological Exam
timeFrame: Day 0, Day 1, Day 2 and Day 3
measure: Change in 12-lead ECG (electrocardiogram)
timeFrame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
measure: Change in Vital signs
timeFrame: Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48
measure: Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets)
timeFrame: Day 0, Day 2 and Day 3
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) after single dose for all periods
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods
timeFrame: 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
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods
timeFrame: 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
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods
timeFrame: 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
measure: Plasma Decay Half-Life (t1/2) after single dose for all periods
timeFrame: 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
measure: Clearance (CL) after single dose for all periods
timeFrame: 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
measure: Volume of Distribution (Vss) after single dose for all periods
timeFrame: 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
measure: Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period
timeFrame: 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
measure: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods
timeFrame: 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
measure: Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods
timeFrame: 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
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: