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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 March 22, 2018
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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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Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Gram-negative Bacterial Infection
  • Drug: AN3365
    LP, 600 mg vial; reconstituted in Normal Saline
  • Drug: Placebo
    0.9% sodium chloride for injection
  • Active Comparator: AN3365
    Intervention: Drug: AN3365
  • Placebo Comparator: Saline
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
August 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01015014
AN3365-PK-101
Yes
Not Provided
Not Provided
Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc.
Pfizer
Not Provided
Study Director: Lee Zane, MD, MAS Pfizer
Pfizer
November 2009

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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