- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462136
PK Study of ACHN-490 Injection in Renally Impaired Subjects
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACHN-490 Injection
|
7.5 mg/kg single dose administered intravenously over 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
0-96 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Days 1 to 14
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Director, Achaogen, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACHN-490-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Insufficiency
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
CHU de ReimsUnknownChronic Renal InsufficiencyFrance
-
Azienda Sanitaria ASL Avellino 2UnknownChronic Renal InsufficiencyItaly
-
Assistance Publique Hopitaux De MarseilleCompletedChronic Renal InsufficiencyFrance
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)CompletedAcute Renal Failure | Chronic Renal InsufficiencyAustria
-
Novartis PharmaceuticalsCompletedChronic Renal InsufficiencyUnited States
-
Weill Medical College of Cornell UniversityGenentech, Inc.SuspendedChronic Renal InsufficiencyUnited States
-
University of Colorado, DenverNational Jewish HealthActive, not recruitingHeart Transplantation | Chronic Renal InsufficiencyUnited States
Clinical Trials on ACHN-490 Injection
-
Achaogen, Inc.CompletedHealthy Volunteers
-
Achaogen, Inc.Department of Health and Human ServicesCompletedA Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy VolunteersCardiac Effects in Normal Healthy VolunteersUnited States
-
Achaogen, Inc.Completed
-
Achaogen, Inc.Defense Medical Research and Development ProgramCompletedHealthy VolunteerUnited States
-
Achaogen, Inc.TerminatedHealthy VolunteerUnited States
-
Mahidol UniversityUniversity of South CarolinaRecruiting
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingRelapsed and/or Refractory Multiple MyelomaChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan