Safety and Tolerability of PF-06818883 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020784
• Other study ID #: C0601001
• Status: Terminated
• Phase: Phase 1
• First received: October 27, 2016
• Last updated: December 7, 2017
• Start date: November 11, 2016
• Est. completion date: June 13, 2017

Study information

• Verified date: December 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety, Tolerability and Pharmacokinetics of PF-06818883

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 13, 2017
• Est. primary completion date: June 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
Placebo
• PF-06818883
Treatment

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Physical examination	Safety test to check overall health	Day 0, Day 1, Day 2 and Day 3
Primary	Change in Neurological Exam	Assessment of sensory neuron and motor responses	Day 0, Day 1, Day 2 and Day 3
Primary	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
Primary	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
Primary	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	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
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods	Tmax after 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
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after 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
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods	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	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
Secondary	Plasma Decay Half-Life (t1/2) after single dose for all periods	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after 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
Secondary	Clearance (CL) after single dose for all periods	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.	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
Secondary	Volume of Distribution (Vss) after single dose for all periods	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.	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
Secondary	Dose-Normalized Maximum Plasma Concentration (Cmax(dn)) after single dose for all period	Dose-Normalized 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
Secondary	Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) after single dose for all periods	Dose Normalized Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast(dn)) after 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
Secondary	Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf(dn))] after single dose for all periods	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	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

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