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

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01015014
First received: October 20, 2009
Last updated: February 21, 2011
Last verified: November 2009
History of Changes

October 20, 2009
February 21, 2011
November 2009
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01015014 on ClinicalTrials.gov Archive Site
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality [ Time Frame: Multiple time points up to 14 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01015014
AN3365-PK-101
Yes
Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
Not Provided
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP