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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: ACHN-490 Injection
Drug: Placebo (normal saline)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACHN-490 Injection
ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.
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.
Placebo Comparator: Placebo is Normal Saline
Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.
Drug: Placebo (normal saline)
Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
Other Names:
  • Normal Saline
  • NS

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034774

Sponsors and Collaborators
Achaogen, Inc.
Investigators
Study Director: Nancy A Havrilla, MS, RN Achaogen, Inc.
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01034774     History of Changes
Other Study ID Numbers: ACHN-490-003
Study First Received: December 16, 2009
Last Updated: February 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Achaogen, Inc.:
Human volunteers

ClinicalTrials.gov processed this record on April 17, 2014