Safety and Tolerability of PF-06818883 in Healthy Subjects | NCT03020784

NCT03020784

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	IV placebo	Drug: Placebo
PF-06818883	Experimental	Experimental drug	Drug: PF-06818883

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo	Placebo
PF-06818883

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) after single dose for all periods	Cmax after a single dose	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

Eligibility Module

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