PK Study of ACHN-490 Injection in Renally Impaired Subjects

NCT01462136 | Completed Phase 1

• 1 other identifier: ACHN-490-004
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Insufficiency

Keywords

PK study

Outcome Measures

Primary Outcomes (1)

• Composite of Pharmacokinetics

  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 Outcomes (1)

• Safety

  Days 1 to 14

Study Arms (1)

ACHN-490 Injection

EXPERIMENTAL

Drug: ACHN-490 Injection

Interventions

ACHN-490 Injection DRUG

7.5 mg/kg single dose administered intravenously over 30 minutes

ACHN-490 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Achaogen, Inc.: lead
• Department of Health and Human Services: collaborator

Related Publications (1)

• Komirenko AS, Riddle V, Gibbons JA, Van Wart S, Seroogy JD. A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01128-18. doi: 10.1128/AAC.01128-18. Print 2018 Dec.

  PMID: 30275092 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

plazomicin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Achaogen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: October 31, 2011
• Study Start: September 1, 2011
• Last Updated: August 23, 2012

Record last verified: 2012-08