Safety and Tolerability of PF-06818883 in Healthy Subjects

Pfizer

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: PF-06818883

Study type

Interventional

Funder types

Industry

Identifiers

NCT03020784

C0601001

Details and patient eligibility

About

Safety, Tolerability and Pharmacokinetics of PF-06818883

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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