A Study to Assess the Safety, Tolerability, and Pharmacok... | NCT01597947

Studies
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers

NCT01597947

Sponsor

Achaogen, Inc.

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

50Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

ACHN-975
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Not provided

Completion Date

Dec 2012Actual

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 11, 2012

First Posted Date

May 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Name	Class
Defense Medical Research and Development Program	UNKNOWN

Description Module

Brief Summary

This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental		Drug: ACHN-975
Arm B	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACHN-975	Drug	Intravenous single dose	Arm A
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of AEs		7 days
Severity of AEs		7 days

Secondary Outcomes

Measure	Description	Time Frame
Plasma concentrations of ACHN-975		2 days
Urine concentrations of ACHN-975		2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Body weight between 40 and 100 kilograms (between ~88 pounds and ~220 pounds)
Use of contraception
Stable health
Negative tests for alcohol, tobacco, and drugs of abuse

Key Exclusion Criteria:

History of clinically significant disease
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Achaogen, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Durham	North Carolina	27705	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000717915	ACHN-975

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided