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OpenTrials
Completed

NCT Number: NCT01034774

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ACHN-490 Injection

Drug

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 (normal saline)

Drug

Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.

Other names: Normal Saline, NS

Primary outcomes

  1. Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days

    Time frame: Throughout the study

Secondary outcomes

  1. Lung penetration as estimated from ACHN-490 measured in ELF

    Time frame: 1 Day

  2. 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

Sponsors and collaborators

Lead sponsor

Achaogen, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2009
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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