PK Study of ACHN-490 Injection in Renally Impaired Subjects

Tracking Information
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; (submitted: October 27, 2011)	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).
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; (submitted: October 27, 2011)	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).
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
Condition ICMJE	Renal Insufficiency
Intervention ICMJE	Drug: ACHN-490 Injection; 7.5 mg/kg single dose administered intravenously over 30 minutes
Study Arms	Experimental: ACHN-490 Injection; Intervention: Drug: ACHN-490 Injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 27, 2011)	24
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Male and female subjects between 18 and 75 years of age and with a body mass index ≥ 19 to ≤ 32 kg/m2, and weight of ≥ 40 kg.; Normal renal function (Group I), or pre-existing renal impairment (Groups II- IV). The disease process responsible for the underlying renal dysfunction must be stable at the time of study entry, and the subject cannot have had episodes of acute renal disease in the year prior to dosing.; Two CrCl determinations obtained during the screening portion of the study, with the lower value within 25% of the higher value.; Females of child-bearing potential (defined as less than one year post-menopause) are eligible for enrollment if they are not breast feeding, they have a negative serum pregnancy test before study entry, and they are willing to use a highly effective method of contraception* for at least three months before study drug administration, during the study, and for at least one month after study completion.; Subjects in stable health as judged by the investigator based on the laboratory criteria and no clinically significant findings on the medical history or physical examination.; Subjects who are willing to comply with all study activities and procedures and have provided written informed consent prior to any study procedures and have signed and dated a HIPAA authorization form. Exclusion Criteria: Subjects requiring hemodialysis or peritoneal dialysis; Unstable cardiovascular disease,; Uncontrolled hypertension, asthma, diabetes (type I or type II), thyroid disease, or seizure disorder.; Myasthenia gravis, or any other neuromuscular disorder.; Known infection with Hepatitis B (antigen positive), Hepatitis C (antibody positive), or HIV.; Active malignancy; carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted.; Presence of functioning transplant organ or blood procedure.; Significant change in either over-the-counter or prescription medications or supplements within the two weeks prior to dosing, defined as any new medication or any dosage adjustment that is significant in the judgment of the investigator and the medical monitor.; Use of drugs known to cause renal disease such as non-steroidal anti-inflammatory drugs in the two weeks prior to dosing.; History of significant hearing loss or a family history of hearing loss, excluding age related (≥ age 65) hearing loss. A prior diagnosis of sensorineural hearing loss or Ménière's disease.; Clinically significant illness, including viral syndromes within three weeks of dosing.; Current participation in a clinical study of an investigational product.; Taken any investigational medication/therapy within 30 days or 5 half-lives, whichever is longer, before dosing of ACHN-490 Injection.; Consumed more than 28 units of ethanol per week at any time in the 6 months before dosing (1 unit of ethanol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of alcoholism and/or drug/chemical abuse. Also, consumption of any amount of ethanol within 48 hours of ACHN-490 Injection dosing.; Donated more than 500 mL of blood within 60 days prior to signing the informed consent form.; Previous participation in this or any other ACHN-490 Injection study.; Known hypersensitivity to Aminoglycosides or any component of the ACHN-490 Injection.; Any other medical, psychological, or social condition which, in the opinion of the principal investigator (PI) or the medical monitor, would prevent the subject from fully participating in the study, would represent a concern for study compliance or would constitute a safety concern to the subject.; An employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employee or investigator.
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Medical Director Achaogen, Inc.
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