Phase 1 Study to Determine Safety, Blood PK and Lung Penetration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT01034774
First received: December 16, 2009
Last updated: February 24, 2012
Last verified: February 2012

December 16, 2009
February 24, 2012
January 2010
June 2010   (final data collection date for primary outcome measure)
Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01034774 on ClinicalTrials.gov Archive Site
  • Lung penetration as estimated from ACHN-490 measured in ELF [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing [ Time Frame: Through 24 hours after the last dose ] [ Designated as safety issue: No ]
  • Lung penetration as estimated from ACHN-490 measured in ELF [ Time Frame: After either 1 or 3 days of dosing ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing [ Time Frame: Through 24 hours after the last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) ACHN-490 in Healthy Subjects

Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: ACHN-490 Injection
    ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment.
  • Drug: Placebo (normal saline)
    Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
    Other Names:
    • Normal Saline
    • NS
  • Active Comparator: ACHN-490 Injection
    ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.
    Intervention: Drug: ACHN-490 Injection
  • Placebo Comparator: Placebo is Normal Saline
    Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.
    Intervention: Drug: Placebo (normal saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or Women
  • Within normal weight limits
  • In good health with normal routine laboratory results
  • Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noises

Exclusion Criteria:

  • No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
  • No problems with hearing or balance
  • No previous injury or surgery to the ears
  • No family history of hearing loss before the age of 65
  • Not taking any medications other than birth control medication
  • Smokers or use of tobacco products
  • Recent blood donors
  • No excessive alcohol intake or illegal substances
  • No allergy to aminoglycosides (a type of antibiotic)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01034774
ACHN-490-003
No
Achaogen, Inc.
Achaogen, Inc.
Not Provided
Study Director: Nancy A Havrilla, MS, RN Achaogen, Inc.
Achaogen, Inc.
February 2012

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