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

Achaogen, Inc.0 sites24 target enrollmentSeptember 2011

ConditionsRenal Insufficiency

InterventionsACHN-490 Injection

DrugsACHN-490 Injection

Overview

Phase: Phase 1
Intervention: ACHN-490 Injection
Conditions: Renal Insufficiency
Sponsor: Achaogen, Inc.
Enrollment: 24
Primary Endpoint: Composite of Pharmacokinetics
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Achaogen, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

ACHN-490 Injection

Intervention: ACHN-490 Injection

Outcomes

Primary Outcomes

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).