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

NCT ID: NCT01015014

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-05
• Study Completion Date: 2010-05-13

Brief 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.

Detailed 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.

Conditions

Gram-negative Bacterial Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AN3365

Group Type: ACTIVE_COMPARATOR

AN3365

Intervention Type: DRUG

LP, 600 mg vial; reconstituted in Normal Saline

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% sodium chloride for injection

Interventions

AN3365

LP, 600 mg vial; reconstituted in Normal Saline

Intervention Type: DRUG

Placebo

0.9% sodium chloride for injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

CMAX

Adelaide, , Australia

Countries

Australia

Other Identifiers

C3501001

Identifier Type: OTHER

Identifier Source: secondary_id

AN3365-PK-101

Identifier Type: -

Identifier Source: org_study_id