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

• Status: Completed
• Trial end date: 2010-05-13
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

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