PK Study of ACHN-490 Injection in Renally Impaired Subjects
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ClinicalTrials.gov Identifier: NCT01462136 |
Recruitment Status
:
Completed
First Posted
: October 31, 2011
Last Update Posted
: August 23, 2012
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Sponsor:
Achaogen, Inc.
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Achaogen, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | September 9, 2011 | |||
First Posted Date ICMJE | October 31, 2011 | |||
Last Update Posted Date | August 23, 2012 | |||
Study Start Date ICMJE | September 2011 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Composite of Pharmacokinetics [ Time Frame: 0-96 hours ] Plasma PK parameters, including area under the curve from time zero to the last quantifiable sample (AUC0-t) and also extrapolated to infinity (AUC0-∞) total clearance (CLT), steady-state volume of distribution (Vss), maximum concentration (Cmax), time to maximum plasma concentration (Tmax), and the terminal-phase half life (t1/2) Urine PK including renal clearance (CLR), fraction of drug excreted in the urine expressed as a percentage of the ACHN-490 dose administered (Ae%), and amount of drug excreted in the urine through 24 hours (Ae0-24) and through 48 hours (Ae0-48). |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01462136 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: Days 1 to 14 ] Safety and tolerability, including adverse events (AEs), and incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis), physical examination, and electrocardiogram (ECG).
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | PK Study of ACHN-490 Injection in Renally Impaired Subjects | |||
Official Title ICMJE | A Phase 1 Study To Assess The Pharmacokinetics, Safety, And Tolerability of Intravenous ACHN-490 Injection in Volunteers With Varying Degrees of Renal Dysfunction Compared to Healthy Volunteers | |||
Brief Summary | The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Renal Insufficiency | |||
Intervention ICMJE | Drug: ACHN-490 Injection
7.5 mg/kg single dose administered intravenously over 30 minutes |
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Study Arms | Experimental: ACHN-490 Injection
Intervention: Drug: ACHN-490 Injection |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
24 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01462136 | |||
Other Study ID Numbers ICMJE | ACHN-490-004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Achaogen, Inc. | |||
Study Sponsor ICMJE | Achaogen, Inc. | |||
Collaborators ICMJE | Department of Health and Human Services | |||
Investigators ICMJE |
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PRS Account | Achaogen, Inc. | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |