Renal InsufficiencyPhase 1NCT01462136
PK Study of ACHN-490 Injection in Renally Impaired Subjects
A Phase 1 study testing ACHN-490 Injection in people with Renal Insufficiency, run by Achaogen, Inc..
Trial summary
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- ACHN-490 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
- Conditions
- Renal Insufficiency
- Being tested
- ACHN-490 Injection
- Keywords
- PK study
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHN-490 InjectionDrug
7.5 mg/kg single dose administered intravenously over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| ACHN-490 Injection | Experimental | Not described Receives: Drug: ACHN-490 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0-96 hours
Secondary outcomes (1)
Safety
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).
Measured: Days 1 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462136
- Sponsor's protocol ID
- ACHN-490-004
- Status last verified
- Aug 2012
- First submitted
- 9 Sep 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30275092
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01462136
- Acronym / sponsor ID
- ACHN-490-004
- Conditions
- Renal Insufficiency
- Keywords
- PK study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Sep 2011
- First posted
- 31 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACHN-490 Injection | Experimental | Drug: ACHN-490 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACHN-490 Injection7.5 mg/kg single dose administered intravenously over 30 minutes | Drug | ACHN-490 Injection |
Primary outcome
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).
1 secondary outcome
Safety
Time frame: Days 1 to 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Derived from this study: PubMed 30275092Komirenko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Achaogen, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACHN-490 Injection in people with Renal Insufficiency, run by Achaogen, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Pharmacokinetics (time frame: 0-96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01462136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.