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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034774
• Other study ID #: ACHN-490-003
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2009
• Last updated: February 24, 2012
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: Achaogen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Achaogen, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days		Throughout the study	Yes
Secondary	Lung penetration as estimated from ACHN-490 measured in ELF		1 Day	No
Secondary	Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing		Through 24 hours after the last dose	No