Safety and Tolerability of PF-06818883 in Healthy Subjects
Study Details
Study Description
Brief Summary
Safety, Tolerability and Pharmacokinetics of PF-06818883
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo IV placebo |
Drug: Placebo
Placebo
|
| Experimental: PF-06818883 Experimental drug |
Drug: PF-06818883
Treatment
|
Outcome Measures
Primary Outcome Measures
- Change in Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Day 0, Day 1, Day 2, Day 3]
An assessment of Adverse Events
- Change in Physical examination [Day 0, Day 1, Day 2 and Day 3]
Safety test to check overall health
- Change in Neurological Exam [Day 0, Day 1, Day 2 and Day 3]
Assessment of sensory neuron and motor responses
- Change in 12-lead ECG (electrocardiogram) [Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48]
heart's electrical activity recorded from electrodes on the body surface
- Change in Vital signs [Day 1 hr 0.25, 1, 2, 6, 8, 12, Day 2 hr 24 and 36, Day 3 hr 48]
clinical measurements, specifically pulse rate, temperature, and blood pressure, that indicate the state of a patient's essential body functions
- Change in Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets) [Day 0, Day 2 and Day 3]
Intended to detect, identify, or quantify one or more significant substances, evaluate organ functions, or establish the nature of a condition
Secondary Outcome Measures
- 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]
Cmax after a single dose
- 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]
Tmax after single dose
- 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 plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
- 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]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
- 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]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
- Clearance (CL) 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]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
- Volume of Distribution (Vss) 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]
Volume of distribution is defined as the volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
- Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period [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]
Dose-Normalized Cmax after a single dose
- Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) 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]
Dose Normalized Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn)) after single dose
- Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] 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]
AUC (0 - inf (dn)) = Dose Normalized Area under the plasma concentration versus time curve (AUC(dn)) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer New Haven Clinical Research Unit | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C0601001