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

Gram-negative Bacterial Infection Clinical Trial

Official title:

First-in-human, Two-stage, Randomized, Placebo-controlled, Double-blind, Dose Escalation Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An3365 In Single And Multiple Doses In Young Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015014
• Other study ID #: AN3365-PK-101
• Secondary ID: C3501001
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2009
• Est. completion date: May 13, 2010

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 13, 2010
• Est. primary completion date: May 13, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-negative Bacterial Infection
• Gram-Negative Bacterial Infections
• Infection

Intervention

Drug:
• AN3365
LP, 600 mg vial; reconstituted in Normal Saline
• Placebo
0.9% sodium chloride for injection

Locations

Country	Name	City	State
Australia	CMAX	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate)		Multiple time points up to 14 days
Secondary	Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality		Multiple time points up to 14 days