Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

Pfizer

Status and phase

Completed

Phase 1

Conditions

Gram-negative Bacterial Infection

Treatments

Drug: AN3365

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01015014

C3501001 (Other Identifier)

AN3365-PK-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.

Full description

Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.

Enrollment

64 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Young healthy males, 18-45 years (inclusive) of age
Healthy as judged by a responsible physician with no clinically significant abnormality
Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during sexual intercourse with a female partner who uses another form of contraception
Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
Non-smokers
Willing and able to comply with study instructions and commit to all follow-up visits
Ability to understand, agree to and sign the study Informed Consent Form (ICF)

Exclusion criteria

History of serious adverse reactions or hypersensitivity to any drug; or who have a known allergy to any of the test product(s) or any components in the test product(s); or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
Any clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions
Abnormal physical findings of clinical significance at the screening examination or baseline
History of orthostatic hypotension
Clinically significant abnormal laboratory values
Presence or history of allergies requiring acute or chronic treatment
12 lead ECG abnormalities
Major surgical interventions within 6 months of the study
Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
Use of prescription or non-prescription drugs
Has a history of regular alcohol consumption
Loss of 500 mL blood or more during the 3 month period before the study
People that follow vegetarian or vegan diet
Symptoms of a significant somatic or mental illness in the four week period preceding drug administration
History of drug abuse or dependence within 12 months of the study
The subject has a positive pre-study alcohol or urine drug screen
Concurrent participation in another drug or device research study or within 60 days of post participation in another drug or device study
Considered by the Investigator to be unsuitable candidate for this study