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
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency||Drug: ACHN-490 Injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2011|
|Experimental: ACHN-490 Injection||
Drug: ACHN-490 Injection
7.5 mg/kg single dose administered intravenously over 30 minutes
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462136
|Study Director:||Medical Director||Achaogen, Inc.|