NCT01015014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

November 5, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2010

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

October 20, 2009

Last Update Submit

March 4, 2019

Conditions

Gram-negative Bacterial Infection

Keywords

Gram negativebacteriainfection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality

    Multiple time points up to 14 days

Study Arms (2)

AN3365

ACTIVE COMPARATOR
Drug: AN3365

Saline

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AN3365DRUG

LP, 600 mg vial; reconstituted in Normal Saline

AN3365
PlaceboDRUG

0.9% sodium chloride for injection

Saline

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, Australia

Location

MeSH Terms

Conditions

Gram-Negative Bacterial InfectionsInfections

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

November 17, 2009

Study Start

November 5, 2009

Primary Completion

May 13, 2010

Study Completion

May 13, 2010

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

AU(1)