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

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NCT01015014

Last updated on November 21, 2019
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FOR MORE INFORMATION
Study Location
CMAX
Adelaide, , Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram-negative Bacterial Infection
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01015014
Pfizer
Completed
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

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[email protected]

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Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionSingle-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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gram-negative Bacterial Infection
Intervention  ICMJE
  • Drug: AN3365
    LP, 600 mg vial; reconstituted in Normal Saline
  • Drug: Placebo
    0.9% sodium chloride for injection
Study Arms  ICMJE
  • Active Comparator: AN3365
    Intervention: Drug: AN3365
  • Placebo Comparator: Saline
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2018)		64
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2009)		88
Actual Study Completion Date  ICMJE May 13, 2010
Actual Primary Completion DateMay 13, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01015014
Other Study ID Numbers  ICMJE AN3365-PK-101
C3501001 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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