End Stage Renal DiseasePhase 1NCT02135276
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects
A Phase 1 study testing eravacycline in people with End Stage Renal Disease, run by Tetraphase Pharmaceuticals, Inc.
Trial summary
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- eravacycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to May 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18 years at Screening;
- Eligible female subjects of childbearing potential with a non-sterilized male sexual partner must agree to use 2 medically accepted, effective methods of birth control (eg, hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning >30 days prior to study drug administration and continuing until 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (ie, >40 IU/L); otherwise these subjects must agree to use contraceptives listed above;
- Male subjects with sexual partners of childbearing potential must agree to use a barrier contraceptive from the time of study drug administration through 7 days after the end of the study;
- Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing (Screening and Day -1);
- Has a body mass index of 17 kg/m2 to 40 kg/m2, inclusive;
- Has negative alcohol and illicit drug screens;
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- Has a negative screen for Human Immunodeficiency Virus;
- Is able to understand and comply with study procedures and give written informed consent according to institutional and regulatory guidelines;
- Subjects with ESRD renal impairment:
- Has a positive diagnosis of ESRD maintained on hemodialysis treatments 3 times a week for at least 3 months with a minimum Kt/V of 1.2;
- Is otherwise considered healthy except for abnormalities consistent with underlying ESRD as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening;
- Healthy subjects without renal impairment:
- Must be in good health as determined by screening medical history, physical examination, vital signs, blood chemistry, hematology, glucose, and coagulation performance at Screening;
- Has a negative screen for hepatitis B (HBV) and hepatitis C (HCV); and
- Should be matched to a subject with renal impairment in gender, age, and BMI.
Who cannot join
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the study;
- Has a history or current evidence of clinically significant hematological, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments;
- Use of another investigational drug or device within 30 days prior to receiving eravacycline (TP-434), or within at least 5 half-lives of the previous investigational drug, whichever is longer;
- Has a history of alcoholism or drug abuse within 6 months prior to dosing;
- Has urinary incontinence;
- Has a typical weekly alcohol consumption of 14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL);
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- Use of alcohol within 48 hours prior to admission until completion of the final PK draw on Day 5;
- Has had a major surgical procedure within 3 months prior to administration of study drug;
- Has known allergies to tetracycline antibiotics or related compounds, or a history of multiple adverse drug allergies of any origin;
- Has inadequate venous access;
- Donated >500 mL of blood within 2 months prior to Screening;
- Is a member of the clinical site personnel directly affiliated with this study;
- Has poor mental function or any other reason to expect subject difficulty in complying with the requirements of the study in the judgment of the investigator;
- Has any surgical or medical condition which might significantly alter the absorption, distribution, or excretion of the drug;
- Fails to comply with protocol requirements, or whose further participation in the study would be unsuitable to the subject, as determined by the investigator;
- Clinically significant abnormal electrocardiograms (ECGs) (QTcF >500 msec);
- Has clinically significant abnormal laboratory value(s), other than those consistent with stage 5 chronic kidney disease. Aspartate aminotransferase or alanine aminotransferase >1.5 × the upper limit of the reference range or total bilirubin >1.5 × the upper limit of the reference range. A single repeat is allowed for eligibility determination;
- Unwillingness to refrain from liquids or food containing grapefruit, cranberry, caffeine, or other xanthines from 96 hours prior to admission until completion of the final PK draw on Day 5;
- Unwillingness to refrain from eating foods containing poppy seeds for 48 hours before admission until completion of the final PK draw on Day 5;
- Unwillingness to abstain from any unaccustomed strenuous exercise or contact sports for at least 72 hours prior to the Screening Visit and 72 hours prior to admission on Day -1 until discharge from the study;
- Subjects with ESRD renal impairment:
- Has active HCV or HBV and is receiving antiviral therapy (either prescribed or herbal);
- Has fluctuating or rapidly deteriorating renal function as indicated by clinical and/or laboratory signs of renal impairment;
- Has signs of active infection;
- Takes any herbal concomitant medication within 7 days, or 5 half-lives (if known), whichever is longer, prior to dosing and within 24 hours after dosing, excluding hormonal contraceptives;
- Subjects without renal impairment:
- Has systolic blood pressure outside of the range of 90-160 mmHg, or diastolic blood pressure outside the range of 45-100 mmHg, or heart rate outside the range of 50 100 bpm for female subjects or 45-100 bpm for male subjects;
- Has a history of Gilbert's disease; or
- Takes any concomitant medication, either prescribed or over the counter. This includes any prescription or non-prescription medication, including vitamins or herbal medications, within 7 days, or 5 half-lives (if known), whichever is longer, prior to dosing and within 24 hours after dosing, excluding hormonal contraceptives. The use of acetaminophen, naproxen, and ibuprofen is permitted except for within 24 hours prior to dosing.
About this study
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).
- Conditions
- End Stage Renal Disease
- Being tested
- eravacycline
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eravacyclineDrug
Also called TP-434
All subjects will receive s single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes on Day 1. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI).
| Study group | Role | What they receive |
|---|---|---|
| End stage renal disease (ESRD) subjects | Experimental | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes Receives: Drug: eravacycline |
| Normal healthy subjects | Experimental | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes Receives: Drug: eravacycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with end stage renal disease (ESRD) compared with normal healthy subjects
Measured: 5 days
Secondary outcomes (1)
Determine the safety and tolerability of eravacycline after administration of a single IV dose (1.5 mg/kg) in subjects with ESRD compared with normal healthy subjects
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135276
- Sponsor's protocol ID
- TP-434-014
- Status last verified
- Dec 2021
- First submitted
- 5 May 2014
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02135276
- Acronym / sponsor ID
- TP-434-014
- Conditions
- End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 May 2014 (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.
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End stage renal disease (ESRD) subjects | Experimental | Drug: eravacyclineA single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
| Normal healthy subjects | Experimental | Drug: eravacyclineA single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female subject aged 18 years at Screening;
- Eligible female subjects of childbearing potential with a non-sterilized male sexual partner must agree to use 2 medically accepted, effective methods of birth control (eg, hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning >30 days prior to study drug administration and continuing until 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (ie, >40 IU/L); otherwise these subjects must agree to use contraceptives listed above;
- Male subjects with sexual partners of childbearing potential must agree to use a barrier contraceptive from the time of study drug administration through 7 days after the end of the study;
- Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing (Screening and Day -1);
- Has a body mass index of 17 kg/m2 to 40 kg/m2, inclusive;
Key exclusion criteria (29 listed)
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the study;
- Has a history or current evidence of clinically significant hematological, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments;
- Use of another investigational drug or device within 30 days prior to receiving eravacycline (TP-434), or within at least 5 half-lives of the previous investigational drug, whichever is longer;
- Has a history of alcoholism or drug abuse within 6 months prior to dosing;
- Has urinary incontinence;
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 |
|---|---|---|
| eravacyclineAlso: TP-434All subjects will receive s single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes on Day 1. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI). | Drug | End stage renal disease (ESRD) subjects, Normal healthy subjects |
Primary outcome
Assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with end stage renal disease (ESRD) compared with normal healthy subjects
Time frame: 5 days
1 secondary outcome
Determine the safety and tolerability of eravacycline after administration of a single IV dose (1.5 mg/kg) in subjects with ESRD compared with normal healthy subjects
Time frame: 5 days
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 17 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eravacycline in people with End Stage Renal Disease, run by Tetraphase Pharmaceuticals, 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 15 inclusion and 29 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 17 Dec 2021. 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?
Assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with end stage renal disease (ESRD) compared with normal healthy subjects (time frame: 5 days). 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 17 Dec 2021.