Impaired Hepatic FunctionPhase 1NCT02135302
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects
A Phase 1 study testing eravacycline in people with Impaired Hepatic Function, run by Tetraphase Pharmaceuticals, Inc at 3 sites in United States.
Trial summary
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 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
- Impaired Hepatic Function
- What is being tested?
- eravacycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Mar 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 (HIV);
- Is able to understand and comply with study procedures and give written informed consent according to institutional and regulatory guidelines;
- Subjects with hepatic impairment:
- Has a positive diagnosis of liver cirrhosis that has been stable for 2 months and is confirmed by imaging techniques, biopsy, or physical signs consistent with a clinical diagnosis of liver cirrhosis (eg, liver firmness to palpation, splenic enlargement, spider angiomata, palmar erythema, parotid hypertrophy, testicular atrophy, gynecomastia);
- Subjects with hepatic impairment must be categorized in 1 of the following:
- Mild hepatic impairment: has impaired but stable hepatic function as evidenced by Child-Pugh Clinical Assessment Score of 5-6 at both Screening and Day -1;
- Moderate hepatic impairment: has impaired but stable hepatic function as evidenced by Child-Pugh Clinical Assessment Score of 7-9 at both Screening and Day -1; or
- Severe hepatic impairment: has impaired but stable hepatic function as evidenced by Child-Pugh Clinical Assessment Score of 10-15 at both Screening and Day -1;
- Healthy subjects without hepatic 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 hepatic 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, renal, 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;
- Evidence of renal impairment with a creatinine clearance of <50 mL/min/1.73m2 as measured by the Cockcroft Gault formula;
- 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 2 years prior to dosing;
- 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 dosing;
- Has had a major surgical procedure within 3 months prior to administration of study drug;
- Has known allergies to tetracycline antibiotic 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;
- Has a change in dose or frequency of any new or chronic dose-adjusted prescription or non-prescription medication, including vitamins or herbal medications, within 7 days or 5 half-lives (if known), whichever is longer, within 2 weeks prior to dosing;
- 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;
- 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) (QTcB or QTcF >500 msec);
- Subjects with hepatic impairment:
- Has active HCV or HBV and is receiving antiviral therapy (either prescribed or herbal);
- Has fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding);
- Has sodium levels 125 mmol/L;
- Has platelets <40,000 × 109/L of blood or evidence of severe active or recent bleeding;
- Has refractory encephalopathy, as judged by the investigator, or significant central nervous system disease (eg, dementia or seizures) which the investigator considers to interfere with informed consent, conduct, completion, or results of this study, or constitutes an unacceptable risk to the subject;
- Has signs of active infection;
- Has experienced esophageal variceal bleeding within the past 6 months;
- Has a Transjugular Intrahepatic Portosystemic Shunt placement;
- Subjects without hepatic impairment:
- Has aspartate aminotransferase or alanine aminotransferase >1.5 × upper limit of normal (ULN); alkaline phosphatase or bilirubin 1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination;
- 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 use of 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Davita Clinical Research
Lakewood, Colorado, 800228
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 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 initiation of study drug administration. Approximately 24 subjects will be enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects will be matched to hepatically 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
- Impaired Hepatic Function
- Being tested
- eravacycline
- Keywords
- hepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eravacyclineDrug
Also called TP-434
Eravacycline (TP-434) is a parenteral and oral antibiotic of the tetracycline class that is highly active in vitro and in established animal infection models against both nosocomial and community-acquired methicillin-susceptible or -resistant Staphylococcus aureus strains, vancomycin-susceptible or -resistant Enterococcus faecium and Enterococcus faecalis, and penicillin-susceptible or -resistant strains of Streptococcus pneumoniae. In addition, eravacycline is highly active against clinically important species of Enterobacteriaceae (including those isolates that produce extended-spectrum β-lactamases and/or are carbapenem-resistant), Acinetobacter baumannii, and anaerobes.
| Study group | Role | What they receive |
|---|---|---|
| Impaired hepatic function | Experimental | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each hepatically impaired subject. Receives: Drug: eravacycline |
| Healthy subjects | Experimental | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each healthy subject. Receives: Drug: eravacycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is being conducted to assess the pharmacokinetic (PK) profile of eravacycline
To assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects
Measured: one year
Secondary outcomes (1)
Safety and tolerability of Eravacycline
To determine the safety and tolerability of eravacycline after administration of a single IV dose (1.5 mg/kg) in subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects.
Measured: one year
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 startOct 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Hepatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Smith, MD, Principal investigator, New Orleans Center for Clinical ResearchThomas Marbury, MD, Principal investigator, Orlando Clinical Research CenterChris Galloway, MD, Principal investigator, Davia Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135302
- Sponsor's protocol ID
- TP-434-013
- 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 Impaired Hepatic Function and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02135302
- Acronym / sponsor ID
- TP-434-013
- Conditions
- Impaired Hepatic Function
- Keywords
- hepatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 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 hepatic impairment and healthy subjects conducted at approximately 3 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 initiation of study drug administration. Approximately 24 subjects will be enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for each of the 3 Child-Pugh categories of mild [5 - 6 points], moderate [7 - 9 points], and severe [10 - 15 points]) and 6 healthy subjects without hepatic impairment. Healthy subjects will be matched to hepatically 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 |
|---|---|---|
| Impaired hepatic function | Experimental | Drug: eravacyclineA single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each hepatically impaired subject. |
| Healthy subjects | Experimental | Drug: eravacyclineA single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each healthy subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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 (30 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, renal, 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;
- Evidence of renal impairment with a creatinine clearance of <50 mL/min/1.73m2 as measured by the Cockcroft Gault formula;
- 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 2 years prior to dosing;
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-434Eravacycline (TP-434) is a parenteral and oral antibiotic of the tetracycline class that is highly active in vitro and in established animal infection models against both nosocomial and community-acquired methicillin-susceptible or -resistant Staphylococcus aureus strains, vancomycin-susceptible or -resistant Enterococcus faecium and Enterococcus faecalis, and penicillin-susceptible or -resistant strains of Streptococcus pneumoniae. In addition, eravacycline is highly active against clinically important species of Enterobacteriaceae (including those isolates that produce extended-spectrum β-lactamases and/or are carbapenem-resistant), Acinetobacter baumannii, and anaerobes. | Drug | Healthy subjects, Impaired hepatic function |
Primary outcome
This study is being conducted to assess the pharmacokinetic (PK) profile of eravacycline
Time frame: one year
To assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects
1 secondary outcome
Safety and tolerability of Eravacycline
Time frame: one year
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.
William Smith, MD principal investigator
New Orleans Center for Clinical Research
Thomas Marbury, MD principal investigator
Orlando Clinical Research Center
Chris Galloway, MD principal investigator
Davia Clinical Research
3 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 eravacycline in people with Impaired Hepatic Function, run by Tetraphase Pharmaceuticals, Inc at 3 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 18 inclusion and 30 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.
Where is the study taking place?
The record lists 3 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?
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?
This study is being conducted to assess the pharmacokinetic (PK) profile of eravacycline (time frame: one year). 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; AzTrials last refreshed its copy on 29 Oct 2026.