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

NCT01034774 | Completed Phase 1

• 1 other identifier: ACHN-490-003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

Human volunteers

Outcome Measures

Primary Outcomes (1)

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

  Throughout the study

Secondary Outcomes (2)

• Lung penetration as estimated from ACHN-490 measured in ELF

  1 Day

• 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

Study Arms (2)

ACHN-490 Injection

ACTIVE COMPARATOR

ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg.

Drug: ACHN-490 Injection

Placebo is Normal Saline

PLACEBO COMPARATOR

Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given.

Drug: Placebo (normal saline)

Interventions

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.

ACHN-490 Injection

Placebo (normal saline) DRUG

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

Also known as: Normal Saline, NS

Placebo is Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Achaogen, Inc.: lead

MeSH Terms

Interventions

plazomicin; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nancy A Havrilla, MS, RN

  Achaogen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 27, 2012

Record last verified: 2012-02