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

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ClinicalTrials.gov Identifier: NCT01015014
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Gram-negative Bacterial Infection Drug: AN3365 Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2009
Actual Primary Completion Date : July 31, 2010
Actual Study Completion Date : August 31, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: AN3365 Drug: AN3365
LP, 600 mg vial; reconstituted in Normal Saline
Placebo Comparator: Saline Drug: Placebo
0.9% sodium chloride for injection



Primary Outcome Measures :
  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) [ Time Frame: Multiple time points up to 14 days ]

Secondary Outcome Measures :
  1. Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality [ Time Frame: Multiple time points up to 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015014


Locations
Australia
CMAX
Adelaide, Australia
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Lee Zane, MD, MAS Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01015014     History of Changes
Other Study ID Numbers: AN3365-PK-101
C3501001 ( Other Identifier: Alias Study Number )
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Pfizer:
Gram negative
bacteria
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Gram-Negative Bacterial Infections