Impaired Renal FunctionPhase 1NCT03776539
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
A Phase 1 study testing ELX-02 in people with Impaired Renal Function, run by Eloxx Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Renal Function
- What is being tested?
- ELX-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2019to 7 Aug 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker and/or light smoker
- Have a diagnosis of renal impairment that has been stable, without any significant change in overall disease status in the last 3 months prior to screening.
- Have an estimated glomerular filtration rate (eGFR) expressed in mL/min/1.73 m2 (Modification of Diet in Renal Disease 4-variable [MDRD4] equation) at screening within the range of:
- Group 1 - Mild Group: 60 - 89 mL/min/1.73 m2;
- Group 2 - Moderate Group: 30 - 59 mL/min/1.73 m2;
- Group 3 - Severe Group: < 30 mL/min/1.73 m2 not requiring dialysis. eGFR results that are deemed inconsistent with the usual stage of renal impairment may be repeated. Subjects are categorized into severity group at screening. If the eGFR scores change on Day-1 or other visit due to a non-clinically significant change in clinical status or laboratory result, the subject keeps the original severity group.
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- Subject may have stable treated medical illnesses and underlying diseases producing the renal impairment such as diabetes, hypertension, or cardiovascular disease, providing that, in the opinion of the PI, the disease is stable.
- Have normal or non-clinically significant findings at physical examination, vital signs and electrocardiogram (ECG) and normal limits or non-clinically significant deviations in clinical laboratory evaluations at screening.
- Other than renal impairment, have no other conditions which may significantly impact study drug absorption or metabolism.
- Stable medical regimen, deemed not to interact with study drug PK, for 14 days prior to dosing, except for routine daily management of electrolytes (e.g. potassium), acid-base, or other associated disorders expected in patients with renal impairment.
- Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use acceptable contraceptive method throughout the study and for 30 days after study drug administration.
- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a non-sterile female partner (sterile female partners include post-menopausal females and surgically sterile females) must be willing to use acceptable contraceptive method from dosing until at least 90 days after study drug administration.
- Male subjects (including men who have had vasectomy) with a pregnant partner must agree to use a condom from dosing until at least 90 days after study drug administration.
- Male subjects must be willing not to donate sperm until 90 days following study drug administration.
- Able to understand and willing to sign the Informed Consent Form (ICF) and comply with the study restrictions.
Who cannot join
- Unstable renal function or acute exacerbation of renal disease within 14 days of study drug administration, as indicated by recent history or worsening of clinical and/or laboratory signs of renal impairment.
- Has a functioning renal transplant.
- Major illness or surgery within 4 weeks prior to dosing.
- Clinically significant unstable medical condition or history of any illness that may increase the risk associated with study participation or investigational drug administration or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
- Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
- History of allergic reactions, hypersensitivity or toxic reactions to aminoglycosides.
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- History of anaphylaxis.
- Supine 12-lead ECG abnormalities at screening considered clinically significant.
- Clinically significant vital sign abnormalities at screening.
- History of significant drug or alcohol abuse within six months prior to screening.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 half-lives, whichever is longer) prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Positive urine drug screen or alcohol test at screening.
- Female subject with positive pregnancy test at screening.
- Breast-feeding or pregnant subject within 6 months prior to study drug administration.
- Use of any drugs known as strong inducer or inhibitor of hepatic drug metabolism within 30 days prior to study drug administration.
- Use of medication other than stable medications approved by the PI and topical products without significant systemic absorption.
- Use of prohibited medications as directed in the protocol.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood within 30 days prior to the first dosing.
- Any reason which, in the opinion of the PI, would prevent the subject from participating in the study.
- Inability to be venipunctured and/or tolerate catheter venous access.
- Presence of mitochondrial mutation(s) making the subject susceptible to aminoglycoside toxicity.
- Presence of signs of dehydration, recent history of neuromuscular blockade or clinically significant history of vestibular impairment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inventiv Health Clinical -Research Pharmacy Unit
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
About this study
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
Read the detailed description
The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group, PK study in subjects with various severities of renal dysfunction and healthy volunteers.
Subjects will be categorized in 4 groups:
Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function
The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in a parallel fashion. At this point, interim PK analyses will be performed and a safety committee composed of Sponsor and Contract Research Organization (CRO) members will jointly review the PK data before dosing the patients with severe renal disease (group 3). Control subjects (group 4) will be recruited after the recruitment of groups 1 to 3.
- Conditions
- Impaired Renal Function
- Being tested
- ELX-02
- Keywords
- Impaired Renal Function, PK
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELX-02Drug
ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.
| Study group | Role | What they receive |
|---|---|---|
| ELX-02 | Experimental | Drug: ELX-02 Receives: Drug: ELX-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters- Plasma AUC0-24
Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Measured: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing
Pharmacokinetic Parameters- Plasma Cmax
Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment
Measured: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
AUC0-inf
Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Measured: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
Pharmacokinetic Parameters - Plasma Tmax
Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Measured: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.
Urine Pharmacokinetics Parameter - Ae0-t
Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose
Measured: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
Urine Pharmacokinetic Parameter - Rmax
Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose
Measured: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]
TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment
Measured: 1-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start4 Jan 2019
- Primary completion30 Jul 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired Renal FunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be categorized in 4 groups: Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eloxx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776539
- Sponsor's protocol ID
- EL-008
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2018
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
- ClinicalTrials.gov ID
- NCT03776539
- Acronym / sponsor ID
- EL-008
- Conditions
- Impaired Renal Function
- Keywords
- Impaired Renal Function, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eloxx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
Detailed description
The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group, PK study in subjects with various severities of renal dysfunction and healthy volunteers.
Subjects will be categorized in 4 groups:
Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function
The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in a parallel fashion. At this point, interim PK analyses will be performed and a safety committee composed of Sponsor and Contract Research Organization (CRO) members will jointly review the PK data before dosing the patients with severe renal disease (group 3). Control subjects (group 4) will be recruited after the recruitment of groups 1 to 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be categorized in 4 groups: Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function
| Arm | Type | Receives |
|---|---|---|
| ELX-02 | Experimental | Drug: ELX-02Drug: ELX-02 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, non-smoker and/or light smoker
- Have a diagnosis of renal impairment that has been stable, without any significant change in overall disease status in the last 3 months prior to screening.
- Have an estimated glomerular filtration rate (eGFR) expressed in mL/min/1.73 m2 (Modification of Diet in Renal Disease 4-variable [MDRD4] equation) at screening within the range of:
- Subject may have stable treated medical illnesses and underlying diseases producing the renal impairment such as diabetes, hypertension, or cardiovascular disease, providing that, in the opinion of the PI, the disease is stable.
- Have normal or non-clinically significant findings at physical examination, vital signs and electrocardiogram (ECG) and normal limits or non-clinically significant deviations in clinical laboratory evaluations at screening.
Key exclusion criteria (22 listed)
- Unstable renal function or acute exacerbation of renal disease within 14 days of study drug administration, as indicated by recent history or worsening of clinical and/or laboratory signs of renal impairment.
- Has a functioning renal transplant.
- Major illness or surgery within 4 weeks prior to dosing.
- Clinically significant unstable medical condition or history of any illness that may increase the risk associated with study participation or investigational drug administration or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
- Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
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 |
|---|---|---|
| ELX-02ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment. | Drug | ELX-02 |
Primary outcome
Pharmacokinetic Parameters- Plasma AUC0-24
Time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing
Area under the curve (AUC0-24) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Pharmacokinetic Parameters- Plasma Cmax
Time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
Peak Plasma Concentration (Cmax) of ELX-02 following a single subcutaneous (SC) dose in subjects with normal renal function, mild, moderate, or severe renal impairment
AUC0-inf
Time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 36, 48, 72, and 168 (Day 8) hours after dosing
Area under the curve (AUC0-inf) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Pharmacokinetic Parameters - Plasma Tmax
Time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing.
Time to maximum concentration (Tmax) of ELX-02 plasma concentration following a single subcutaneous (SC) dose
Urine Pharmacokinetics Parameter - Ae0-t
Time frame: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
Cumulative amount of unchanged drug excreted into urine (Ae0-t) of ELX-02 following a single subcutaneous (SC) dose
Urine Pharmacokinetic Parameter - Rmax
Time frame: Pre-dose (first void in the morning of Day 1), 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36, 36-48, and 48-72 hours post-dose
Maximum rate of urinary extraction (Rmax) of ELX-02 following a single subcutaneous (SC) dose
Number of Patients Reporting Treatment-Emergent Adverse Events (TEAEs) [Safety]
Time frame: 1-8 days
TEAEs are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Description Eloxx Pharmaceuticals WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELX-02 in people with Impaired Renal Function, run by Eloxx Pharmaceuticals, Inc. at 2 sites in United States.
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 15 inclusion and 22 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetic Parameters- Plasma AUC0-24 (time frame: 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, and 24 hours after dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.